PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
NCT ID: NCT00085384
Last Updated: 2012-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2002-07-31
2007-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PEG-interferon alfa-2b
Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
PEG-interferon alfa-2b
Starting dose 1.0 mg/kg/week given subcutaneously
Arm II
Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
PEG-interferon alfa-2b
Biological/Vaccine: PEG-interferon alfa-2b
Dose 1.25 mg/kg/week given subcutaneously
Arm III
Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
PEG-interferon alfa-2b
Biological/Vaccine: PEG-interferon alfa-2b
Dose 1.5 mg/kg/week given subcutaneously
EG-Intron
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PEG-interferon alfa-2b
Starting dose 1.0 mg/kg/week given subcutaneously
PEG-interferon alfa-2b
Biological/Vaccine: PEG-interferon alfa-2b
Dose 1.25 mg/kg/week given subcutaneously
PEG-interferon alfa-2b
Biological/Vaccine: PEG-interferon alfa-2b
Dose 1.5 mg/kg/week given subcutaneously
EG-Intron
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Judith K. Wolf, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Pedro T. Ramirez, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Diane C. Bodurka, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
M D Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
UT MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDA-ID-02115
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000368964
Identifier Type: REGISTRY
Identifier Source: secondary_id
ID02-115
Identifier Type: -
Identifier Source: org_study_id