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

Benaroya Research Institute40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

Interventions

TopotecanDRUG

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

BevacizumabDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Virginia Mason Medical Center

Seattle, Washington, United States

Puget Sound Oncology Consortium (PSOC)

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.

Secondary Outcomes

Evaluation of Overall Survival

Overall survival was defined as the number of months after commencing study treatment to death.

Time frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.

Objective Response Rate

RECIST criteria

Time frame: Response

Number or Participants With Toxicity

Time frame: measured at each treatment cycle

Data from ClinicalTrials.gov

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