Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer

• Status: Terminated
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy alone; 2) how effective interferon gamma-1b plus standard chemotherapy is in preventing the progression or return of cancer; 3) the effects on quality of life; and 4) the safety of interferon gamma-1b combined with standard chemotherapy compared to chemotherapy alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InterMune
• Treatments: Interferon-gamma; Interferons

Criteria

Inclusion criteria:

• Histologically confirmed epithelial ovarian or primary peritoneal carcinoma, FIGO Stage III or IV disease. Patients with either optimal (<= 1 cm residual disease) or suboptimal residual disease following initial surgery are eligible. Unstained slides of the primary tumor, a primary tumor block, or cytological preparation must be available for review.

• Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.

• <= 12 weeks after initial surgery with adequate recovery from surgery.

• Candidate for first-line chemotherapy

• Adequate bone marrow function (ANC >= 1,500/mL; platelets >= 100,000/mL; hemoglobin >= 10 gm/dL)

• Adequate hepatic function (AST, ALT, and alkaline phosphatase <= 2.5 x upper limit of normal; bilirubin <= 1.5 x upper limit of normal).

• Adequate renal function (creatinine <= 1.5 x upper limit of normal).

• Adequate neurologic function (sensory and motor neuropathy <= NCI CTC Grade 1).

• Negative urine pregnancy test in women of child-bearing potential (within 14 days of the initiation of the first chemotherapy cycle).

• Zubrod / ECOG / GOG performance score 0-2.

• Able to give informed consent.

Exclusion criteria:

• Epithelial ovarian tumors of low malignant potential (borderline carcinomas). If diagnosis is based on cytology alone [(e.g., fine needle aspiration (FNA)], slides must be available, and confounding carcinomas such as non-ovarian mucinous, colorectal, Fallopian tube, and other adenocarcinomas of non-ovarian origin must be ruled out.

• Prior therapy for ovarian or primary peritoneal carcinoma other than primary surgical debulking.

• Patients for whom therapy for ovarian or primary peritoneal carcinoma in addition to protocol therapy is planned.

• Prior biological response modifier (BRM) for any reason within the previous 5 years.

• Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. Patients who have had a malignancy > 5 years previously may be eligible for this trial if they have not received any anti-neoplastic treatment within the previous 5 years an dif they have been without any evidence of disease for the previous 5 years.

• Uncontrolled infection.

• Pregnant or nursing women are excluded. Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the dosing portion of the study.

• Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.