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

NCT00047632 | Terminated Phase 3

• 1 other identifier: GIOV-001
• Study Type: interventional
• Target: 847
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Carcinoma; Peritoneal Carcinoma

Keywords

ovarian; carcinoma; peritoneal; cancer; ovary; interferon gamma

Outcome Measures

Primary Outcomes (1)

• Overall survival time assessed at end of study

  4 years

Secondary Outcomes (3)

• 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

Interventions

Interferon gamma-1b DRUG

100 mcg, SQ, 3x per week

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InterMune: lead

Study Sites (1)

InterMune, Inc.

Brisbane, California, 94005, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma; Neoplasms

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• InterMune, Inc. 888-486-6411

  Medical Information

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 9, 2002
• First Posted: October 11, 2002
• Study Start: October 1, 2001
• Study Completion: February 1, 2006
• Last Updated: November 1, 2007

Record last verified: 2007-10

Locations

US (1)