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

Stopped early · Phase 1/Phase 2

Conditions studied: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

In brief

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.

Key facts

Study ID

NCT00085384

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2002-07-01

Expected to finish

2007-04-01

Last updated by the study team

2012-08-02

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Progression of disease during platinum chemotherapy, or
• Progression of disease within 6 months of completing platinum chemotherapy
• 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
• Patients with a known hypersensitivity to platinum compounds who have failed a desensitization regimen, or who are not good candidates for desensitization are eligible.
• Patients are limited to 4 prior chemotherapy regimens (all platinum and taxane regimens to be counted as one).
• Patients must have measurable disease.
• Women of any racial and ethnic group.
• Zubrod performance status < 2.
• Expected survival of > 12 weeks.
• Patients must have adequate hepatic, renal, and bone marrow function, defined as serum creatinine < 2 mg/dl (estimated creatinine clearance 50 ml/min); total bilirubin < 2.0 X the upper limit of normal (ULN); alanine aminotransferase (ALT) < 2X ULN; fasting triglycerides < 800 mg/dL; white blood count (WBC) > 3,000/mm3 ; absolute neutrophil count (ANC) > 1,500/mm3; platelets > 100,000/mm3, hemoglobin > 9 g/dl.
• At least three weeks must have elapsed from completion of chemotherapy.
• Patient agrees not to use complementary alternative medications (e.g., shark cartilage).
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the hospital. The only approved consent is appended to this protocol.

You may not qualify if…

• Patients with borderline, low grade or low malignant potential tumors are not eligible.
• Patients who are pregnant or lactating.
• Concurrent chemotherapy, radiation therapy or surgery.
• Concurrent, uncontrolled, medical or psychiatric disorders.
• Patients with a known hypersensitivity to interferon.
• Patients with severe cardiovascular disease (i.e. arrhythmias requiring chronic treatment or congestive heart failure) (NYHA classification III or IV).
• Patients who have had interferon within the last 6 months.
• Patients with overt psychosis or mental disability or otherwise incompetent to give informed consent.
• Patients with a known autoimmune disorder.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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