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

Ovarian Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00047632
• Other study ID #: GIOV-001
• Status: Terminated
• Phase: Phase 3
• First received: October 9, 2002
• Last updated: October 30, 2007
• Start date: October 2001
• Est. completion date: February 2006

Study information

• Verified date: October 2007
• Source: InterMune
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 847
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Carcinoma
• Ovarian Neoplasms
• Peritoneal Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	InterMune, Inc.	Brisbane	California

Sponsors (1)

Lead Sponsor	Collaborator
InterMune

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival time assessed at end of study		4 years
Secondary	Progression-free survival time assessed at interim analysis		4 years
Secondary	Treatment failure-free survival time assessed at end of study		4 years
Secondary	Quality of life assessed through 24 months after end of treatment		4 years