Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer
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ClinicalTrials.gov Identifier: NCT00047632 |
Recruitment Status
:
Terminated
(futility)
First Posted
: October 11, 2002
Last Update Posted
: November 1, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Carcinoma Peritoneal Carcinoma | Drug: Interferon gamma-1b | Phase 3 |
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 |

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Drug: Interferon gamma-1b
- Overall survival time assessed at end of study [ Time Frame: 4 years ]
- Progression-free survival time assessed at interim analysis [ Time Frame: 4 years ]
- Treatment failure-free survival time assessed at end of study [ Time Frame: 4 years ]
- Quality of life assessed through 24 months after end of treatment [ Time Frame: 4 years ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047632
United States, California | |
InterMune, Inc. | |
Brisbane, California, United States, 94005 |
OverallOfficial: | InterMune, Inc. 888-486-6411 | Medical Information |
ClinicalTrials.gov Identifier: | NCT00047632 History of Changes |
Other Study ID Numbers: |
GIOV-001 |
First Posted: | October 11, 2002 Key Record Dates |
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 |