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Study Title: Weekly Topotecan (HyCamtin®) with Bevacizumab (Avastin®) Ovarian, Fallopian tube and/or Peritoneal Cancer
Category: Cancer, General

Currently accepting participants?
Yes - please read the description below and contact the study coordinator if you are interested.

Principal Investigator: Thomas Malpass, MD
Study Coordinator: Louise Soltow
Phone: (206) 583-6559 Ext.68710
Email: Louise.Soltow@vmmc.org

What is the Weekly Topotecan (HyCamtin®) with Bevacizumab (Avastin®) Ovarian, Fallopian tube and/or Peritoneal Cancer study?

One arm study, that is open (unblinded). 40 subjects to be enrolled. Staging every 3 months using CT. Collection of complication information for safety assessments and tolerability. Topotecan may be dose reduced for decreased cell counts. Topotecan cannot be held for more than 2 weeks without study discontinuation. Bevacizumab will not be reduced in dose, but may be held.

Who can participate?

Patients with recurrent, cis-platinum resistent ovarian, fallopian tube and/or peritoneal cancer. No major bleeding or cardiac problems including uncontrolled hypertension. Adequate hematology and chemistry. Patients must have measurable lesions on CT and/or increased CA125 (> 100).

What do I have to do as a study participant?

Provide informed consent. Come to the Oncology Clinic for treatment once per week for 3 weeks. Have CT done every 3 months. Be followed by research staff.

Study Summary:

This Phase II study is for patients with recurrent, cis-platinum resistent ovarian, fallopian tube and/or peritoneal cancer. Weekly Intravenous infusions of topotecan with bevacizumab will be assessed for efficacy, safety and tolerability. Topotecan will be given once every week for 3 weeks. Bevacizumab will be given every other week. The 4th week is a "rest" week. Both medications are FDA approved. We are trying to ment option for your condition.

Detailed Study Description:

The cycle of treatment is 28 days (4 weeks). Bevacizumab is given first on days 1 and 8 at 10 mg/kg. Topotecan is given at 4 mg/m2 on days 1, 8 and 21. Patients rest the 4th week without treatment. We will test your blood (hematology - every week for 3 weeks, and chemistry and liver enzymes - on day 1 of each cycle). Urine chemistry will be tested (on day 1, every other cycle). We will test the CA125 marker on day 1 of each cycle (about once per month).

What does the study pay for? The study provides the 2 study medications. The study pays for the urine chemistry.

Study Design: Interventional
Phase of Study: Phase II
Study Type: Interventional
Condition or Study Focus: Ovarian, fallopian tube and/or peritoneal cancer - recurrent and cisplatinum resistent
Intervention Type: Intravenous/ through port - drugs
Intervention Name: bevacizumab and topotecan (in order of administration)
Gender: Female
Age group: Interventional
Sponsor: GlaxoSmithKline & Genentech, Inc.

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