NCT00085384

PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	PEG-interferon alfa-2b	Starting dose 1.0 mg/kg/week given subcutaneously
DRUG	PEG-interferon alfa-2b	Biological/Vaccine: PEG-interferon alfa-2b Dose 1.25 mg/kg/week given subcutaneously
BIOLOGICAL	PEG-interferon alfa-2b	Biological/Vaccine: PEG-interferon alfa-2b Dose 1.5 mg/kg/week given subcutaneously EG-Intron

Timeline

• Start date: 2002-07-01
• Primary completion: 2005-11-01
• Completion: 2007-04-01
• First posted: 2004-06-11
• Last updated: 2012-08-02

Locations

1 site across 1 country: United States