Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary or primary peritoneal carcinoma.

• Relapsed after prior therapy with taxane and platinum-based therapy, within 6 months of completing, or had a best response of stable disease during no more than two prior chemotherapy treatments with a platinum (either cisplatin or carboplatin) and a taxane (paclitaxel or docetaxel). These agents may have been administered concurrently or sequentially. Besides the primary chemotherapy, two additional chemotherapy regimens are allowed. Hormonal therapy is allowed and will not be counted as a chemotherapy regimen.

• Up to one year of consolidation treatment with intraperitoneal and intravenous administered chemotherapy drugs to consolidate a clinical complete remission is allowed.

• Patients must have elevated CA-125 or measurable disease.

• For patients who do not have RECIST measurable disease, an elevated CA-125 (greater than two times the institutional upper limit of normal) will be required for enrollment.

• Debulking surgery for relapsed disease is allowed but must be completed at least 28 days prior to the first day of study therapy. Patient must have recovered from all side effects of surgery including a completely healed surgical incision.

• Patient must have a Zubrod performance status of 0-1.

• Patient must have adequate hepatic function as defined by:

• a serum bilirubin ≤1.5 x the institutional upper limit of normal (IULN),

• SGOT or SGPT ≤2.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy

• Patient must have an adequate renal function as defined by:

• a serum creatinine ≤1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy and a urine protein:creatinine (UPC) ratio of ≤ 1.0.

• Patients must be able to take oral medications

• Patients may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.

• Patients must have the following hematological criteria:

• Hemoglobin of >10gm/dL,

• White blood cell count >2500,

• Platelets >80,000

• Patients must be ≥ 18 years of age.

Exclusion Criteria:

• Subjects with mixed mullerian tumors and borderline ovarian tumors are excluded. Patients with a history of borderline ovarian tumors that have evolved into higher grade tumors will be eligible.

• The patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.

• Patient must not be pregnant or nursing because bevacizumab or erlotinib maybe harmful to the developing fetus and newborn. Women of reproductive potential must have a negative serum pregnancy test within 7 days prior to study consent. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

• Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.

• Except for cancer-related abnormalities, patients should not have unstable or preexisting major medical conditions.

• Patients should not have any medical life-threatening complications of their malignancies

• Patients should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV)

• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.

• Baseline blood pressure of < or equal to 150/100 mmHg. Patients with a blood pressure reading above this level should be initiated on anti-hypertensive therapy and may be considered for protocol treatment when their blood pressure is adequately controlled.

• New York Heart Association (NYHA) Grade II or greater congestive heart failure

• History of myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within 6 months

• Clinically significant peripheral vascular disease

• Evidence of bleeding diathesis or coagulopathy

• Presence of central nervous system or brain metastases

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study

• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0

• Pregnant (positive pregnancy test) or lactating

• Urine protein:creatinine ratio > equal to 1.0 at screening

• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess

• Serious, non-healing wound, ulcer, or bone fracture

• Diagnosis of any other malignancy except non-melanomatous skin cancer in the past 5 years.

• Inability to comply with study and/or follow-up procedures