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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Benaroya Research Institute
Study ID
NCT00343044
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 22, 2006
Start date
Jun 30, 2006
Status verified
Apr 2015
Primary completion
Jan 31, 2010
Completion
Aug 31, 2011

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Progression Free Survival [ Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Puget Sound Oncology Consortium (PSOC)SeattleWashington98104-
Virginia Mason Medical CenterSeattleWashington98101-

Find similar trials in Seattle, WA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Puget Sound Oncology Consortium (PSOC)· Seattle, WAVirginia Mason Medical Center· Seattle, WA

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