Study Stopped
Terminated due to slow accrual.
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
5 other identifiers
interventional
30
1 country
1
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 see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2002
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 10, 2004
CompletedFirst Posted
Study publicly available on registry
June 11, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedAugust 2, 2012
August 1, 2012
3.3 years
June 10, 2004
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Optimal Biologic Dose at 8 weeks
Optimum biologic dose of PEG Intron in patients with platinum-resistant ovarian, fallopian tube or peritoneal cancer whose tumors test positive for IL-8, BFGF, or VEGF.
8 weeks
Tumor Response
Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.
Every 2 -3 cycles (8 - 12 weeks)
Study Arms (3)
PEG-interferon alfa-2b
EXPERIMENTALPatients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
Arm II
EXPERIMENTALPatients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
Arm III
EXPERIMENTALPatients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
Interventions
Starting dose 1.0 mg/kg/week given subcutaneously
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Judith K. Wolf, MD
M.D. Anderson Cancer Center
- STUDY CHAIR
Pedro T. Ramirez, MD
M.D. Anderson Cancer Center
- STUDY CHAIR
Diane C. Bodurka, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2004
First Posted
June 11, 2004
Study Start
July 1, 2002
Primary Completion
November 1, 2005
Study Completion
April 1, 2007
Last Updated
August 2, 2012
Record last verified: 2012-08