PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

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

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