Brief Title
PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
Official Title
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
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.
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 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Optimal Biologic Dose at 8 weeks
Condition
Fallopian Tube Cancer
Intervention
PEG-interferon alfa-2b
Study Arms / Comparison Groups
PEG-interferon alfa-2b
Description: Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
30
Start Date
July 2002
Completion Date
April 2007
Primary Completion Date
November 2005
Eligibility Criteria
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.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Judith K. Wolf, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00085384
Organization ID
ID02-115
Secondary IDs
P50CA083639
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Judith K. Wolf, MD, Study Chair, M.D. Anderson Cancer Center
Verification Date
August 2012