Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Completed · Phase 2

Conditions studied: Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

In brief

This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.

Key facts

Study ID

NCT00126542

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2005-04-01

Expected to finish

2010-04-01

Last updated by the study team

2014-05-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
• Recurrent or metastatic disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Must have received a platinum-containing chemotherapy regimen for primary disease
• Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval > 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum
• Patients with a treatment-free interval < 12 months do not require prior chemotherapy for recurrent disease
• No evidence of CNS disease, including primary brain tumors or brain metastasis
• Performance status - ECOG 0-2
• More than 3 months
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No history of bleeding diathesis
• SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis)
• Bilirubin normal
• INR ≤ 1.5 (3 if receiving warfarin)
• No history of esophageal varices
• Creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 60 mL/min
• Urine protein < 1+
• Urine protein < 1,000 mg on 24-hour urine collection
• Urine protein:creatinine ratio < 1.0
• No arterial thromboembolic event within the past 6 months, including any of the following:
• Transient ischemic attack
• Cerebrovascular accident

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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