safety and efficacy of interferon gamma-1b plus chemotherapy for ovarian and peritoneal cancer

Conditions: Ovarian Carcinoma; Peritoneal Carcinoma

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.

approximately 800 patients will receive either chemotherapy alone or chemotherapy plus interferon gamma-1b. chemotherapy will be paclitaxel (175 mg/m2 over 3 hours) followed by carboplatin (auc 6) every 3 weeks. only those patients in the treatment arm will receive interferon doses. interferon gamma-1b 100 mg will be administered subcutaneously 3 times per week (every other day; no more than 3 doses in a 7-day period) continuously while patients are treated with carboplatin / paclitaxel (including for the 3 weeks following the last dose of chemotherapy). a total of 6 cycles of chemotherapy will be given unless disease progression or liming toxicity occurs or patients refuse further treatment. each patient will receive a total of 54 doses over a period of 18 weeks. each patient's participation will be from 3-8 years in duration.

Eligibility 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.

Keywords: ovarian carcinoma peritoneal cancer ovary interferon gamma