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

This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00085384
First received: June 10, 2004
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: PEG-interferon alfa-2b
Drug: PEG-interferon alfa-2b
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Optimal Biologic Dose at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Tumor Response [ Time Frame: Every 2 -3 cycles (8 - 12 weeks) ] [ Designated as safety issue: Yes ]
    Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.


Enrollment: 30
Study Start Date: July 2002
Study Completion Date: April 2007
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-interferon alfa-2b
Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
Biological: PEG-interferon alfa-2b
Starting dose 1.0 mg/kg/week given subcutaneously
Other Name: PEG-Intron
Experimental: Arm II
Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
Drug: PEG-interferon alfa-2b

Biological/Vaccine: PEG-interferon alfa-2b

Dose 1.25 mg/kg/week given subcutaneously

Other Name: PEG-Intron
Experimental: Arm III
Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
Biological: PEG-interferon alfa-2b

Biological/Vaccine: PEG-interferon alfa-2b

Dose 1.5 mg/kg/week given subcutaneously

EG-Intron

Other Name: PEG-Intron

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085384

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00085384     History of Changes
Other Study ID Numbers: ID02-115, P50CA083639, P30CA016672, MDA-ID-02115, CDR0000368964
Study First Received: June 10, 2004
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
recurrent ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Interferon-alpha
Interferons
Peginterferon alfa-2b
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014