Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer |
Drug: bevacizumab and topotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers |
- Progression Free Survival
- Evaluation of overall survival, complete response, partial response, stable disease, and
- measure effect of this treatment on CA-125 levels
- Evaluation of toxicities: type and severity
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2006 |
This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. The toxicities of each of these agents is quite different. Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. In our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg IV every other week.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| Puget Sound Oncology Consortium (PSOC) | |
| Seattle, Washington, United States | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Principal Investigator: | Kathryn McGonigle, MD | Virginia Mason Medical Center |
More Information
Additional Information:
No publications provided by Benaroya Research Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00343044 History of Changes |
| Other Study ID Numbers: | 3040200, AVF3648s |
| Study First Received: | June 20, 2006 |
| Last Updated: | May 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Benaroya Research Institute:
|
platinum resistant ovarian cancer recurrent ovarian cancer platinum resistant cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Topotecan Bevacizumab Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013