NCT00011986 · STUDY IN CONTEXT

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Proportion of participants whose overall survival exceeded 5 years.

All enrolled participants.

→

primary · POSTED

Median duration in months of progression free survival.

Source null

→

secondary · POSTED

Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0

Eligible and treated participants

→

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-ovarian-neoplasm-cisplatin-6f0c5203
nct id: NCT00011986
trial label: Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 3
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0000
source section id
NCT00011986-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Proportion of participants whose overall survival exceeded 5 years.
time origin
Up to 9 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled participants.
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-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0001
source section id
NCT00011986-om-0001
source outcome index
1
endpoint
Progression-free Survival
endpoint definition
Median duration in months of progression free survival.
time origin
From the date of enrollment to first progression or death or last contact, if alive and progression free.
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-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0002
source section id
NCT00011986-om-0002
source outcome index
2
endpoint
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
endpoint definition
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
time origin
Up to 9 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated participants
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-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0000
arm key
OG000
arm label
Carbo/Taxol
regimen
Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
analyzed count
864
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0000
arm key
OG001
arm label
Carbo/Taxol/Gemcitabine
regimen
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
analyzed count
864
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0000
arm key
OG002
arm label
Carbo/Taxol/Doxil
regimen
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
analyzed count
862
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0000
arm key
OG003
arm label
Carbo/Topotecan - Carbo/Taxol
regimen
Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
analyzed count
861
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0000
arm key
OG004
arm label
Carbo/Gemcitabine - Carbo/Taxol
regimen
Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
analyzed count
861
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0001
arm key
OG000
arm label
Carbo/Taxol
regimen
Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
analyzed count
864
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0001
arm key
OG001
arm label
Carbo/Taxol/Gemcitabine
regimen
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
analyzed count
864
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0001
arm key
OG002
arm label
Carbo/Taxol/Doxil
regimen
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
analyzed count
862
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0001
arm key
OG003
arm label
Carbo/Topotecan - Carbo/Taxol
regimen
Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
analyzed count
861
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0001
arm key
OG004
arm label
Carbo/Gemcitabine - Carbo/Taxol
regimen
Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
analyzed count
861
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0002
arm key
OG000
arm label
Grade 3 and Above on ToxicityCarbo/Taxol
regimen
Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
analyzed count
862
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
outcome key
om-0002
arm key
OG001
arm label
Grade 3 and Above on Carbo/Taxol/Gemcitabine
regimen
Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
analyzed count
860
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00011986-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
harm key
EG000
source section id
NCT00011986-ae
event group key
EG000
event group label
Carbo/Taxol
serious affected
86
serious at risk
777
other affected
857
other at risk
862
frequency threshold
0
collection period
From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred.
event definition
Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
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-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
harm key
EG001
source section id
NCT00011986-ae
event group key
EG001
event group label
Carbo/Taxol/Gemcitabine
serious affected
107
serious at risk
774
other affected
856
other at risk
860
frequency threshold
0
collection period
From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred.
event definition
Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
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-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
harm key
EG002
source section id
NCT00011986-ae
event group key
EG002
event group label
Carbo/Taxol/Doxil
serious affected
115
serious at risk
767
other affected
852
other at risk
854
frequency threshold
0
collection period
From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred.
event definition
Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
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-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
harm key
EG003
source section id
NCT00011986-ae
event group key
EG003
event group label
Carbo/Topotecan - Carbo/Taxol
serious affected
77
serious at risk
766
other affected
843
other at risk
846
frequency threshold
0
collection period
From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred.
event definition
Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
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-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT00011986
harm key
EG004
source section id
NCT00011986-ae
event group key
EG004
event group label
Carbo/Gemcitabine - Carbo/Taxol
serious affected
100
serious at risk
767
other affected
849
other at risk
851
frequency threshold
0
collection period
From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred.
event definition
Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
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