Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Completed · Phase 2
Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer
In brief
This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
Key facts
- Study ID
- NCT00022659
- Run by
- National Cancer Institute (NCI)
- People needed
- 64
- Starts
- 2002-04-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2019-07-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
- Recurrent or persistent after initial standard surgery or chemotherapy
- Incurable with standard surgery, chemotherapy, or radiotherapy
- At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- Outside the area of prior radiotherapy
- Accessible to guided core needle biopsy
- Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or another organoplatinum compound) for primary disease
- May have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
- Patients with only 1 prior platinum-based chemotherapy regimen must have an initial treatment-free interval of less than 12 months
- Patients with an initial treatment-free interval of more than 12 months must have progressive disease after prior platinum-based chemotherapy regimen as second-line therapy
- No tumors involving major blood vessels
- No evidence of CNS disease (primary brain tumor or brain metastases) within the past 5 years
- Ineligible for higher priority Gynecologic Oncology Group (GOG) protocols (i.e., active phase III GOG protocols for the same patient population)
- Performance status - GOG 0-2 (patients who have received 1 prior regimen)
- Performance status - GOG 0-1 (patients who have received 2 prior regimens)
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- No known bleeding disorder or coagulopathy
- No active bleeding
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- serum glutamate oxaloacetate transaminase (SGOT) ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- PT (INR) ≤ 1.5 (INR 2-3 if on stable dose of therapeutic warfarin or low molecular weight heparin)
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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