A Phase II Trial of Bevacizumab (NSC# 704865) and OSI-774 (NSC# 718781) In Recurrent Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma
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