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

Launched by INTERMUNE · Oct 10, 2002

Keywords

ClinConnect Summary

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 ...

Gender

FEMALE

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.