Status:
TERMINATED
PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
Phase:
PHASE1
PHASE2
Brief 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 ...
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 to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00085384
Start Date
July 1 2002
End Date
April 1 2007
Last Update
August 2 2012
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030