TriangleNCT00262847 · STUDY IN CONTEXT
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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 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
Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).
Median overall survival (OS)
Eligible and Evaluable patients
Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.
Reported safety
Quality of life and patient-reported measures
FACT · Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- qol key
- qol-0003
- source section id
- NCT00262847-om-0003
- source outcome index
- 3
- instrument
- FACT
- instrument basis
- matched 'fact-o' in the study's own wording
- scale title
- Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)
- measure definition
- Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.
- time frame
- At baseline, 9, 18, 36, 60, and 84 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Number of valid QOL assessments do not total number of patients randomized in study.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- trial label
- Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
- 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
- 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
- 4
- harms Count
- 3
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0000
- source section id
- NCT00262847-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival
- endpoint definition
- Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).
- time origin
- From study entry until first disease progression, death or date of last contact, up to 6 years
- 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
- nct id
- NCT00262847
- outcome key
- om-0001
- source section id
- NCT00262847-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Median overall survival (OS)
- time origin
- From study entry to death or last contact, up to 6 years
- analysis role
- secondary
- 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
- nct id
- NCT00262847
- outcome key
- om-0002
- source section id
- NCT00262847-om-0002
- source outcome index
- 2
- endpoint
- Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0
- endpoint definition
- Eligible and Evaluable patients
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and evaluable 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-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0003
- source section id
- NCT00262847-om-0003
- source outcome index
- 3
- endpoint
- Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)
- endpoint definition
- Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.
- time origin
- At baseline, 9, 18, 36, 60, and 84 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Number of valid QOL assessments do not total number of patients randomized in study.
- 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
- nct id
- NCT00262847
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Placebo, Paclitaxel, Carboplatin)
- regimen
- Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
- analyzed count
- 625
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
- regimen
- Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
- analyzed count
- 625
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Arm III (Paclitaxel, Carboplatin, Bevacizumab)
- regimen
- Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
- analyzed count
- 623
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (Placebo, Paclitaxel, Carboplatin)
- regimen
- Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
- analyzed count
- 625
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
- regimen
- Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
- analyzed count
- 625
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Arm III (Paclitaxel, Carboplatin, Bevacizumab)
- regimen
- Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
- analyzed count
- 623
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I Toxicities (Placebo, Paclitaxel, Carboplatin)
- regimen
- Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
- analyzed count
- 621
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab)
- regimen
- Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
- analyzed count
- 624
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)
- regimen
- Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
- analyzed count
- 619
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I (Placebo, Paclitaxel, Carboplatin)
- regimen
- Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
- analyzed count
- 625
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
- regimen
- Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
- analyzed count
- 625
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Arm III (Paclitaxel, Carboplatin, Bevacizumab)
- regimen
- Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
- analyzed count
- 623
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00262847-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- harm key
- EG000
- source section id
- NCT00262847-ae
- event group key
- EG000
- event group label
- Arm I (Placebo, Paclitaxel, Carboplatin)
- serious affected
- 239
- serious at risk
- 621
- other affected
- 589
- other at risk
- 621
- frequency threshold
- 5
- collection period
- All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adeverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
- event definition
- Source null
- 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
- nct id
- NCT00262847
- harm key
- EG001
- source section id
- NCT00262847-ae
- event group key
- EG001
- event group label
- Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
- serious affected
- 257
- serious at risk
- 624
- other affected
- 593
- other at risk
- 624
- frequency threshold
- 5
- collection period
- All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adeverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
- event definition
- Source null
- 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
- nct id
- NCT00262847
- harm key
- EG002
- source section id
- NCT00262847-ae
- event group key
- EG002
- event group label
- Arm III (Paclitaxel, Carboplatin, Bevacizumab)
- serious affected
- 287
- serious at risk
- 619
- other affected
- 588
- other at risk
- 619
- frequency threshold
- 5
- collection period
- All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adeverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
- event definition
- Source null
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00262847
- qol key
- qol-0003
- source section id
- NCT00262847-om-0003
- source outcome index
- 3
- instrument
- FACT
- instrument basis
- matched 'fact-o' in the study's own wording
- scale title
- Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)
- measure definition
- Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.
- time frame
- At baseline, 9, 18, 36, 60, and 84 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Number of valid QOL assessments do not total number of patients randomized in study.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice