Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.
- 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.
- 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
- Prior therapy for ovarian or primary peritoneal carcinoma other than primary surgical
- 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.