RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
OBJECTIVES: * Determine the optimum biologic dose of PEG-interferon alfa-2b in patients with platinum-resistant ovarian epithelial, peritoneal, or fallopian tube cancer. * Determine the safety and tolerability of this drug in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 different treatment arms. * Arm I: Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22. * Arm II: Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22. * Arm III: Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22. In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 28 days after study treatment. PROJECTED ACCRUAL: A maximum of 75 patients will be accrued for this study within 19 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Starting dose 1.0 mg/kg/week given subcutaneously
Biological/Vaccine: PEG-interferon alfa-2b Dose 1.25 mg/kg/week given subcutaneously
Biological/Vaccine: PEG-interferon alfa-2b Dose 1.5 mg/kg/week given subcutaneously EG-Intron
M D Anderson Cancer Center
Houston, Texas, United States
Optimal Biologic Dose at 8 weeks
Optimum biologic dose of PEG Intron in patients with platinum-resistant ovarian, fallopian tube or peritoneal cancer whose tumors test positive for IL-8, BFGF, or VEGF.
Time frame: 8 weeks
Tumor Response
Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.
Time frame: Every 2 -3 cycles (8 - 12 weeks)
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