Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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.

exploratory · NOT_POSTED

These were blood and tissue samples collections and have no data to report.

Source null

→

exploratory · NOT_POSTED

These were blood and tissue samples collections and have no data to report.

Source null

→

primary · POSTED

Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method.

All randomized patients

→

secondary · POSTED

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) was defined as the time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who were still alive and progression free were censored at last disease assessment date. Median PFS was estimated using Kaplan-Meier method.

All randomized patients

→

secondary · POSTED

Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).

All randomized patients

→

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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id: NCT00588770
trial label: Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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: 5
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0003
source section id
NCT00588770-om-0003
source outcome index
3
endpoint
To Collect Blood Samples Before and After Therapy for Future Correlative Studies
endpoint definition
These were blood and tissue samples collections and have no data to report.
time origin
Before and after therapy
analysis role
exploratory
reporting status
NOT_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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0004
source section id
NCT00588770-om-0004
source outcome index
4
endpoint
To Collect Tumor Tissue Samples Available at Baseline From Prior Diagnostic Procedures for Future Correlative Studies
endpoint definition
These were blood and tissue samples collections and have no data to report.
time origin
Baseline
analysis role
exploratory
reporting status
NOT_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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0000
source section id
NCT00588770-om-0000
source outcome index
0
endpoint
Overall Survival (OS)
endpoint definition
Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method.
time origin
assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0001
source section id
NCT00588770-om-0001
source outcome index
1
endpoint
Progression-free Survival (PFS)
endpoint definition
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) was defined as the time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who were still alive and progression free were censored at last disease assessment date. Median PFS was estimated using Kaplan-Meier method.
time origin
on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0002
source section id
NCT00588770-om-0002
source outcome index
2
endpoint
Overall Response Rate
endpoint definition
Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).
time origin
on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized patients
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0000
arm key
OG000
arm label
Chemotherapy Arm (Arm A)
regimen
ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
200
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00588770-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0000
arm key
OG001
arm label
Chemotherapy+Bevacizumab (Arm B)
regimen
ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. Regimen 2: ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. Regimen 2 carbo: ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00588770-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0001
arm key
OG000
arm label
Chemotherapy Arm (Arm A)
regimen
ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
200
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00588770-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0001
arm key
OG001
arm label
Chemotherapy+Bevacizumab (Arm B)
regimen
ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. Regimen 2: ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. Regimen 2 carbo: ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00588770-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0002
arm key
OG000
arm label
Chemotherapy Arm (Arm A)
regimen
ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
200
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00588770-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
outcome key
om-0002
arm key
OG001
arm label
Chemotherapy+Bevacizumab (Arm B)
regimen
ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. Regimen 2: ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. Regimen 2 carbo: ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00588770-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
harm key
EG000
source section id
NCT00588770-ae
event group key
EG000
event group label
Chemotherapy (Arm A)
serious affected
135
serious at risk
199
other affected
50
other at risk
199
frequency threshold
5
collection period
Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events)
event definition
At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT00588770
harm key
EG001
source section id
NCT00588770-ae
event group key
EG001
event group label
Chemotherapy + Bevacizumab (Arm B)
serious affected
162
serious at risk
193
other affected
50
other at risk
193
frequency threshold
5
collection period
Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events)
event definition
At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
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