A Phase I/II Study to Evaluate the Optimum Dose of Pegylated-Interferon (PEG INTRON) in Patients With Platinum Resistant Ovarian, Peritoneal or Fallopian Tube Cancer
- 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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Judith K. Wolf, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|