Clinical trial · Interventional
Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
NCT00343044CI-TRIAL-00017927completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.
- interventionNames
- Drug: Topotecan
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
- description
- Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * must have received primary taxane and platinum-based chemotherapy and no more than 1 other chemotherapy regimen * must have platinum resistant disease(defined as recurrence within 6 months of receiving platinum based chemotherapy, first or second line) * must have measurable disease (greater than 20mm by conventional techniques or 10mm by spiral CT) OR elevated CA-125 (\> 100 on two occasions at least one week apart * performance status greater than or equal to 70% Exclusion Criteria: * prior treatment with anti-angiogenesis agent * treatment with \> 2 cytotoxic regimens (including primary platinum and taxane chemotherapy) * evidence of other malignancy within 3 years of study enrollment * history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation * history of intra-abdominal abscess with 6 months prior to day 0 * pregnant or lactating patients
References
Publications (1)
- RESULTMcGonigle KF, Muntz HG, Vuky J, Paley PJ, Veljovich DS, Greer BE, Goff BA, Gray HJ, Malpass TW. Combined weekly topotecan and biweekly bevacizumab in women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer: results of a phase 2 study. Cancer. 2011 Aug 15;117(16):3731-40. doi: 10.1002/cncr.25967. Epub 2011 Feb 24. PMID 21815133