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

TERMINATEDPHASE1/PHASE2

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

NCT00085384•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Women with platinum-resistant epithelial ovarian, fallopian tube or peritoneal cancer whose tumor test positive for IL-8 (\>31.0 pg/ml), bFGF \>7.0 pg/ml), or VEGF (\>700 pg/ml). Resistance is defined as:
•1. Progression of disease during platinum chemotherapy, or
•2. Progression of disease within 6 months of completing platinum chemotherapy
•3. Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status
•2. Patients with a known hypersensitivity to platinum compounds who have failed a desensitization regimen, or who are not good candidates for desensitization are eligible.
•3. Patients are limited to 4 prior chemotherapy regimens (all platinum and taxane regimens to be counted as one).
•4. Patients must have measurable disease.
•5. Women of any racial and ethnic group.
•6. Zubrod performance status \< 2.
•7. Expected survival of \> 12 weeks.
+4 more criteria

Exclusion Criteria

•2. Patients who are pregnant or lactating.
•3. Concurrent chemotherapy, radiation therapy or surgery.
•4. Concurrent, uncontrolled, medical or psychiatric disorders.
•5. Patients with a known hypersensitivity to interferon.
•6. Patients with severe cardiovascular disease (i.e. arrhythmias requiring chronic treatment or congestive heart failure) (NYHA classification III or IV).
•7. Patients who have had interferon within the last 6 months.
•8. Patients with overt psychosis or mental disability or otherwise incompetent to give informed consent.
•9. Patients with a known autoimmune disorder.

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

July 1, 2002

Primary Completion Date

November 1, 2005

Completion Date

April 1, 2007

Last Updated

August 2, 2012

Enrollment

ACTUAL participants

Conditions

Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer

Interventions

PEG-interferon alfa-2b

BIOLOGICAL

PEG-interferon alfa-2b

DRUG

PEG-interferon alfa-2b

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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