Status:
COMPLETED
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ca...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with bevacizumab and erloti...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Unstable angina pectoris
- Myocardial infarction
- No clinically significant peripheral artery disease
- No uncontrolled hypertension
- No New York Heart Association grade II-IV congestive heart failure
- No serious cardiac arrhythmia requiring medication
- No peripheral vascular disease ≥ grade 2
- Not pregnant
- No nursing during and for ≥ 3 months after study participation
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after study participation
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies)
- No serious or non-healing wound, ulcer, or bone fracture
- No active infection requiring parenteral antibiotics
- No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No gastrointestinal tract disease resulting in an inability to take oral medication
- No significant traumatic injury within the past 28 days
- No known HIV positivity
- No prior bevacizumab
- See Disease Characteristics
- No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory disease (i.e., failed to achieve a clinical CR after primary therapy)
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to any indicator lesion unless disease has progressed since completion of radiotherapy
- More than 4 weeks since prior major surgical procedure or open biopsy
- More than 1 week since prior core biopsy
- No prior surgery affecting absorption
- No concurrent major surgery
- Recovered from prior therapy
- No prior vascular endothelial growth factor (VEGF) or an epidermal growth factor receptor (EGFR) directed therapy
- No prior erlotinib
- At least 30 days since prior investigational drugs
- More than 1 month since prior thrombolytic agents
- Concurrent warfarin allowed provided the following criteria are met:
- Patient is on a therapeutic stable dose of warfarin
- INR ≤ 3
- No active bleeding or pathological condition that would confer a high risk of bleeding (e.g., tumor invading adjacent organs or major blood vessels or varices that are likely to bleed)
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00126542
Start Date
April 1 2005
End Date
April 1 2010
Last Update
May 14 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637