Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers

NCT ID: NCT00343044

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

Topotecan

Intervention Type: DRUG

Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.

Bevacizumab

Intervention Type: DRUG

bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.

Interventions

Topotecan

Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.

Intervention Type: DRUG

Bevacizumab

bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.

Intervention Type: DRUG

Other Intervention Names

Hycamtin; Avastin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Beth Edelheit

Thomas Malpass, MD, Kathryn McGonigle, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn McGonigle, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

Virginia Mason Medical Center

Seattle, Washington, United States

Puget Sound Oncology Consortium (PSOC)

Seattle, Washington, United States

Countries

United States

References

McGonigle 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.

Reference Type: RESULT

PMID: 21815133 (View on PubMed)

Related Links

http://www.benaroyaresearch.org

Benaroya Research Institute's homepage with listings of clinical trials

Other Identifiers

AVF3648s

Identifier Type: OTHER

Identifier Source: secondary_id

3040200

Identifier Type: -

Identifier Source: org_study_id