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← Ovarian Neoplasm

NCT00434642 · STUDY IN CONTEXT

A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube 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 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

PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.

Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).

→

secondary · POSTED

An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.

Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).

→

secondary · POSTED

Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.

Subset of the intent-to-treat population: All patients randomized to treatment who achieved an objective response.

→

secondary · POSTED

Overall survival was defined as the time from randomization to death from any cause.

Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).

→

secondary · POSTED

A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.

Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.

→

secondary · POSTED

Percentage of Patients Who Had at Least 1 Adverse Event

Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.

→

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
nct id
NCT00434642
trial label
A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube 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
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
6
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0000
    source section id
    NCT00434642-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
    endpoint definition
    PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
    time origin
    From randomization through September 17, 2010 (up to 3 years, 5 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0001
    source section id
    NCT00434642-om-0001
    source outcome index
    1
    endpoint
    Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
    endpoint definition
    An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
    time origin
    From randomization through September 17, 2010 (up to 3 years, 5 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0002
    source section id
    NCT00434642-om-0002
    source outcome index
    2
    endpoint
    Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
    endpoint definition
    Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
    time origin
    From randomization through September 17, 2010 (up to 3 years, 5 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Subset of the intent-to-treat population: All patients randomized to treatment who achieved an objective response.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0003
    source section id
    NCT00434642-om-0003
    source outcome index
    3
    endpoint
    Overall Survival
    endpoint definition
    Overall survival was defined as the time from randomization to death from any cause.
    time origin
    From randomization through July 19, 2013 (up to 6 years, 3 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0004
    source section id
    NCT00434642-om-0004
    source outcome index
    4
    endpoint
    Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)
    endpoint definition
    A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.
    time origin
    From randomization through September 17, 2010 (up to 3 years, 5 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0005
    source section id
    NCT00434642-om-0005
    source outcome index
    5
    endpoint
    Percentage of Patients Who Had at Least 1 Adverse Event
    endpoint definition
    Percentage of Patients Who Had at Least 1 Adverse Event
    time origin
    From randomization through July 19, 2013 (up to 6 years, 3 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Carboplatin and Gemcitabine + Bevacizumab
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Carboplatin and Gemcitabine + Placebo
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Carboplatin and Gemcitabine + Bevacizumab
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Carboplatin and Gemcitabine + Placebo
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Carboplatin and Gemcitabine + Bevacizumab
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
    analyzed count
    190
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Carboplatin and Gemcitabine + Placebo
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Carboplatin and Gemcitabine + Bevacizumab
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Carboplatin and Gemcitabine + Placebo
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
    analyzed count
    242
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Carboplatin and Gemcitabine + Bevacizumab
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
    analyzed count
    247
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Carboplatin and Gemcitabine + Placebo
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
    analyzed count
    233
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Carboplatin and Gemcitabine + Bevacizumab
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
    analyzed count
    247
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Carboplatin and Gemcitabine + Placebo
    regimen
    Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
    analyzed count
    233
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00434642-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    harm key
    EG000
    source section id
    NCT00434642-ae
    event group key
    EG000
    event group label
    Carboplatin and Gemcitabine + Bevacizumab
    serious affected
    90
    serious at risk
    247
    other affected
    246
    other at risk
    247
    frequency threshold
    5
    collection period
    From randomization through July 19, 2013
    event definition
    Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm
    nct id
    NCT00434642
    harm key
    EG001
    source section id
    NCT00434642-ae
    event group key
    EG001
    event group label
    Carboplatin and Gemcitabine + Placebo
    serious affected
    59
    serious at risk
    233
    other affected
    233
    other at risk
    233
    frequency threshold
    5
    collection period
    From randomization through July 19, 2013
    event definition
    Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.
    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