Sequential Angiogenic Blockade for the Treatment of Recurrent Mullerian Malignancies
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT00856180
- Phase
- PHASE2
- Status
- Completed
Conditions
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUG
- Cyclophosphamide — DRUG
Study Details
The goals of this study were to evaluate the efficacy and safety of sequentially blocking the angiogenesis pathway via known antiangiogenic mechanisms, first with bevacizumab and then addition of oral cyclophosphamide upon progression of cancer through bevacizumab. The drugs used in this study were chosen because of their known antiangiogenic properties, tolerability, and anti-ovarian cancer effects.
Key Dates
- First listed
- Mar 5, 2009
- Start date
- Feb 28, 2009
- Status verified
- Aug 2018
- Primary completion
- Apr 30, 2010
- Completion
- Jan 31, 2014
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Bevacizumab then Cyclophosphamide with BevacizumabPatients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 2 cycles/6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) \[RECIST 1.0 or Rustin criteria\] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
Primary Outcome Measure
Therapy Completion Rate [ Time Frame: Serologic and radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7). ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
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