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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Ovarian Carcinoma; Peritoneal Carcinoma	Drug: Interferon gamma-1b	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	847 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.
Study Start Date :	October 2001
Actual Study Completion Date :	February 2006

Arms and Interventions

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Intervention Details:

Drug: Interferon gamma-1b
100 mcg, SQ, 3x per week

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Progression-free survival time assessed at interim analysis [ Time Frame: 4 years ]
2. Treatment failure-free survival time assessed at end of study [ Time Frame: 4 years ]
3. Quality of life assessed through 24 months after end of treatment [ Time Frame: 4 years ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
InterMune, Inc.
Brisbane, California, United States, 94005

Sponsors and Collaborators

InterMune

Investigators

OverallOfficial:	InterMune, Inc. 888-486-6411	Medical Information

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00047632 History of Changes
Other Study ID Numbers:	GIOV-001
First Posted:	October 11, 2002
Last Update Posted:	November 1, 2007
Last Verified:	October 2007

Keywords provided by InterMune:

ovarian; carcinoma; peritoneal	cancer; ovary; interferon gamma

Additional relevant MeSH terms:

Carcinoma; Ovarian Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female	Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Interferons; Interferon-gamma; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents