NCT01064648 · STUDY IN CONTEXT

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

MTD was determined by testing dose-de-escalation to 20mg PO daily on dose de-escalation cohort 1 to 2 with 3 to 6 patients each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. Toxicities will be graded according to the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events. Dose-limiting toxicities (DLT) apply only during Cycle 1 and must be drug-related (i.e. possibly, probably or definitely related to one of the 3 study drugs). The following events occurring in the first cycle of treatment are considered dose limiting. 1. Febrile neutropenia 2. Grade 4 neutrophil count decrease for more than 7 days' duration 3. Grade 4 platelet count decrease 4. Grade 3 or 4 non-hematologic toxicity (excluding alopecia)

Source null

→

primary · POSTED

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesions, or the appearance of new lesions.

Only eligible and analyzable patients were included.

→

secondary · POSTED

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Only eligible and analyzable patients are included in the analysis.

→

secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. All target measurable lesions must be assessed using the same techniques as baseline.

Only eligible patients with baseline measurable disease per RECIST 1.1 were included in the analysis.

→

secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA): Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA All target measurable lesions must be assessed using the same techniques as baseline.

Eligible patients with baseline eligible disease per RECIST 1.1 were included in the analysis.

→

secondary · POSTED

Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. All target measurable lesions must be assessed using the same techniques as baseline.

Eligible patients with baseline measurable disease per modified RECIST were included in the analysis.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-malignant-mesothelioma
nct id: NCT01064648
trial label: Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0000
source section id
NCT01064648-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)
endpoint definition
MTD was determined by testing dose-de-escalation to 20mg PO daily on dose de-escalation cohort 1 to 2 with 3 to 6 patients each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. Toxicities will be graded according to the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events. Dose-limiting toxicities (DLT) apply only during Cycle 1 and must be drug-related (i.e. possibly, probably or definitely related to one of the 3 study drugs). The following events occurring in the first cycle of treatment are considered dose limiting. 1. Febrile neutropenia 2. Grade 4 neutrophil count decrease for more than 7 days' duration 3. Grade 4 platelet count decrease 4. Grade 3 or 4 non-hematologic toxicity (excluding alopecia)
time origin
Weekly during first cycle (1cycle = 21 days). Then will be reported every cycle while patient is on treatment.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0001
source section id
NCT01064648-om-0001
source outcome index
1
endpoint
Progression-free Survival (Phase II)
endpoint definition
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesions, or the appearance of new lesions.
time origin
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever came first, assessed up to 5 years.Disease assessment will be repeated every 6 weeks until disease progression.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only eligible and analyzable patients were included.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0002
source section id
NCT01064648-om-0002
source outcome index
2
endpoint
Overall Survival (Phase II)
endpoint definition
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
time origin
From date of registration to death.Disease assessment will be repeated every 6 weeks until disease progression. After progression, follow up will occur every 6 months for the first two years and then at the end of the third year after registration.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only eligible and analyzable patients are included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0003
source section id
NCT01064648-om-0003
source outcome index
3
endpoint
Response Rate by RECIST1.1 (Phase II)
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. All target measurable lesions must be assessed using the same techniques as baseline.
time origin
Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years. Best response is documented for as long as the patient remains on protocol treatment.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only eligible patients with baseline measurable disease per RECIST 1.1 were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0004
source section id
NCT01064648-om-0004
source outcome index
4
endpoint
Disease Control Rate by RECIST 1.1 (Phase II)
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA): Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA All target measurable lesions must be assessed using the same techniques as baseline.
time origin
Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control rate is documented for as long as the patient remains on protocol treatment.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with baseline eligible disease per RECIST 1.1 were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0005
source section id
NCT01064648-om-0005
source outcome index
5
endpoint
Response Rate by Modified RECIST (Phase II)
endpoint definition
Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. All target measurable lesions must be assessed using the same techniques as baseline.
time origin
Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Best response is documented for as long as the patient remains on protocol treatment.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible patients with baseline measurable disease per modified RECIST were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0000
arm key
OG000
arm label
All Phase I Participants
regimen
All participants from Phase I who are eligible for DLT. Patients will be considered evaluable for DLT if they received at least 14 doses of cediranib at the assigned dose during Cycle 1 and at least one dose each of pemetrexed and cisplatin, or if they developed a DLT. If a patient does not develop a DLT but does not complete at least 14 doses of cediranib and one dose each of pemetrexed and cisplatin during Cycle 1 due to any reason, the patient will be considered not evaluable for DLT and will be replaced.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0001
arm key
OG000
arm label
Phase II Cisplatin-pemetrexed Cediranib 20mg
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0001
arm key
OG001
arm label
Phase II Cisplatin-pemetrexed Placebo
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0002
arm key
OG000
arm label
Phase II Cisplatin-pemetrexed Cediranib 20mg
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0002
arm key
OG001
arm label
Phase II Cisplatin-pemetrexed Placebo
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0003
arm key
OG000
arm label
Phase II Cisplatin-pemetrexed Cediranib 20mg
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
35
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0003
arm key
OG001
arm label
Phase II Cisplatin-pemetrexed Placebo
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0004
arm key
OG000
arm label
Phase II Cisplatin-pemetrexed Cediranib 20mg
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
35
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0004
arm key
OG001
arm label
Phase II Cisplatin-pemetrexed Placebo
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0005
arm key
OG000
arm label
Phase II Cisplatin-pemetrexed Cediranib 20mg
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
outcome key
om-0005
arm key
OG001
arm label
Phase II Cisplatin-pemetrexed Placebo
regimen
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064648-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
harm key
EG000
source section id
NCT01064648-ae
event group key
EG000
event group label
Phase I Cisplatin-pemetrexed Cediranib 30mg
serious affected
4
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
For phase I patients, adverse assessment is repeated weekly during first cycle (1 cycle = 21 days), then every cycle until patient is off protocol treatment. For phase II patients, adverse assessment is repeated every cycle until patient is off protocol treatment, up to 3 years.
event definition
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
harm key
EG001
source section id
NCT01064648-ae
event group key
EG001
event group label
Phase I Cisplatin-pemetrexed Cediranib 20mg
serious affected
6
serious at risk
13
other affected
13
other at risk
13
frequency threshold
5
collection period
For phase I patients, adverse assessment is repeated weekly during first cycle (1 cycle = 21 days), then every cycle until patient is off protocol treatment. For phase II patients, adverse assessment is repeated every cycle until patient is off protocol treatment, up to 3 years.
event definition
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
harm key
EG002
source section id
NCT01064648-ae
event group key
EG002
event group label
Phase II Cisplatin-pemetrexed Cediranib 20mg
serious affected
32
serious at risk
44
other affected
42
other at risk
44
frequency threshold
5
collection period
For phase I patients, adverse assessment is repeated weekly during first cycle (1 cycle = 21 days), then every cycle until patient is off protocol treatment. For phase II patients, adverse assessment is repeated every cycle until patient is off protocol treatment, up to 3 years.
event definition
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-mesothelioma
nct id
NCT01064648
harm key
EG003
source section id
NCT01064648-ae
event group key
EG003
event group label
Phase II Cisplatin-pemetrexed Placebo
serious affected
25
serious at risk
46
other affected
43
other at risk
46
frequency threshold
5
collection period
For phase I patients, adverse assessment is repeated weekly during first cycle (1 cycle = 21 days), then every cycle until patient is off protocol treatment. For phase II patients, adverse assessment is repeated every cycle until patient is off protocol treatment, up to 3 years.
event definition
For Adverse Event assessment, we include patients who are eligible and evaluable for adverse events (e.g., received at least one dose of protocol treatment) in the analysis. For all-cause mortality, we include all eligible patients in the analysis.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice