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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00047632
• Date of registration: 09/10/2002
• Primary sponsor: InterMune
• Public title: Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer
• Scientific title: Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.
• Date of first enrolment: October 2001
• Target sample size: 847
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00047632
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: InterMune, Inc. 888-486-6411
• Affiliation: Medical Information

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Carcinoma

Peritoneal Carcinoma

Intervention(s)

Drug: Interferon gamma-1b

Primary Outcome(s)

Overall survival time assessed at end of study [Time Frame: 4 years]

Secondary Outcome(s)

Progression-free survival time assessed at interim analysis [Time Frame: 4 years]

Quality of life assessed through 24 months after end of treatment [Time Frame: 4 years]

Treatment failure-free survival time assessed at end of study [Time Frame: 4 years]

Secondary ID(s)

GIOV-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors