Ovarian Carcinoma, Peritoneal Carcinoma
Conditions
Keywords
ovarian, carcinoma, peritoneal, cancer, ovary, interferon gamma
Brief 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.
Detailed description
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.
Interventions
DRUGInterferon gamma-1b
100 mcg, SQ, 3x per week
Sponsors
InterMune
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival time assessed at end of study | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival time assessed at interim analysis | 4 years |
| Treatment failure-free survival time assessed at end of study | 4 years |
| Quality of life assessed through 24 months after end of treatment | 4 years |
Countries
United States
Outcome results
None listed