search
Back to results

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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PEG-interferon alfa-2b
PEG-interferon alfa-2b
PEG-interferon alfa-2b
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PEG-interferon alfa-2b

Arm II

Arm III

Arm Description

Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.

Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.

Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
August 1, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00085384
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to slow accrual.
Study Start Date
July 2002 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEG-interferon alfa-2b
Arm Type
Experimental
Arm Description
Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
Arm Title
Arm III
Arm Type
Experimental
Arm Description
Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
Intervention Type
Biological
Intervention Name(s)
PEG-interferon alfa-2b
Other Intervention Name(s)
PEG-Intron
Intervention Description
Starting dose 1.0 mg/kg/week given subcutaneously
Intervention Type
Drug
Intervention Name(s)
PEG-interferon alfa-2b
Other Intervention Name(s)
PEG-Intron
Intervention Description
Biological/Vaccine: PEG-interferon alfa-2b Dose 1.25 mg/kg/week given subcutaneously
Intervention Type
Biological
Intervention Name(s)
PEG-interferon alfa-2b
Other Intervention Name(s)
PEG-Intron
Intervention Description
Biological/Vaccine: PEG-interferon alfa-2b Dose 1.5 mg/kg/week given subcutaneously EG-Intron
Primary Outcome Measure Information:
Title
Optimal Biologic Dose at 8 weeks
Description
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.
Time Frame
8 weeks
Title
Tumor Response
Description
Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.
Time Frame
Every 2 -3 cycles (8 - 12 weeks)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith K. Wolf, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pedro T. Ramirez, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Diane C. Bodurka, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs