NCT00072566 · STUDY IN CONTEXT
Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal 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
Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.
Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.
Calculated using the method of Kaplan-Meier.
Reported safety
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
- NCT00072566
- trial label
- Bevacizumab and Low-Dose Cyclophosphamide in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal 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
- 3
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00072566
- outcome key
- om-0000
- source section id
- NCT00072566-om-0000
- source outcome index
- 0
- endpoint
- Median Time to Progression
- endpoint definition
- Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.
- time origin
- Up to 3 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
- NCT00072566
- outcome key
- om-0001
- source section id
- NCT00072566-om-0001
- source outcome index
- 1
- endpoint
- Response Rate Based on the RECIST
- endpoint definition
- Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.
- time origin
- Up to 3 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
- NCT00072566
- outcome key
- om-0002
- source section id
- NCT00072566-om-0002
- source outcome index
- 2
- endpoint
- Median Overall Survival
- endpoint definition
- Calculated using the method of Kaplan-Meier.
- time origin
- Time from first day of treatment to time of death due to any cause, assessed up to 3 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00072566
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Bevacizumab, Cyclophosphamide)
- regimen
- Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV cyclophosphamide: Given PO
- analyzed count
- 70
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00072566-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00072566
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Bevacizumab, Cyclophosphamide)
- regimen
- Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV cyclophosphamide: Given PO
- analyzed count
- 70
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00072566-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00072566
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Bevacizumab, Cyclophosphamide)
- regimen
- Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. bevacizumab: Given IV cyclophosphamide: Given PO
- analyzed count
- 70
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00072566-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-neoplasm
- nct id
- NCT00072566
- harm key
- EG000
- source section id
- NCT00072566-ae
- event group key
- EG000
- event group label
- Treatment (Bevacizumab, Cyclophosphamide)
- serious affected
- 23
- serious at risk
- 70
- other affected
- 70
- other at risk
- 70
- frequency threshold
- 0
- collection period
- Source null
- event definition
- "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
- 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
Triangle