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

Date de début de l'étude : 1 juillet 2002

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. 8. 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. 9. At least three weeks must have elapsed from completion of chemotherapy. 10. Patient agrees not to use complementary alternative medications (e.g., shark cartilage). 11. 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 Criteria: 1. Patients with borderline, low grade or low malignant potential tumors are not eligible. 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.