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

Ovarian Cancer Clinical Trial

Official title:

Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343044
• Other study ID #: 3040200
• Secondary ID: AVF3648s
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2006
• Last updated: April 29, 2015
• Start date: June 2006
• Est. completion date: August 2011

Study information

• Verified date: April 2015
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• Topotecan
Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.
• Bevacizumab
bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.

Locations

Country	Name	City	State
United States	Puget Sound Oncology Consortium (PSOC)	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Benaroya Research Institute	Genentech, Inc., GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	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.	PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.	No
Secondary	Evaluation of Overall Survival	Overall survival was defined as the number of months after commencing study treatment to death.	PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.	No
Secondary	Objective Response Rate	RECIST criteria	Response	No
Secondary	Number or Participants With Toxicity		measured at each treatment cycle	Yes

External Links

•   Benaroya Research Institute's homepage with listings of clinical trials