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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00085384
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date July 2002
Completion date April 2007

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