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Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.

Phase 3
Not Enrolling
Ovarian Carcinoma, Peritoneal Carcinoma

Thank you

Trial Information

Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.

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.

Inclusion 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Overall survival time assessed at end of study

Outcome Time Frame:

4 years

Principal Investigator

InterMune, Inc. 888-486-6411

Investigator Affiliation:

Medical Information


United States: Food and Drug Administration

Study ID:




Start Date:

October 2001

Completion Date:

February 2006

Related Keywords:

  • Ovarian Carcinoma
  • Peritoneal Carcinoma
  • ovarian
  • carcinoma
  • peritoneal
  • cancer
  • ovary
  • interferon gamma
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



InterMune, Inc. Brisbane, California  94005