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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00085384
• Other study ID #: ID02-115
• Secondary ID: P50CA083639P30CA
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 10, 2004
• Last updated: August 1, 2012
• Start date: July 2002
• Est. completion date: April 2007

Study information

• Verified date: August 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: April 2007
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Biological:
• PEG-interferon alfa-2b
Starting dose 1.0 mg/kg/week given subcutaneously

Drug:
• PEG-interferon alfa-2b
Biological/Vaccine: PEG-interferon alfa-2b Dose 1.25 mg/kg/week given subcutaneously

Biological:
• PEG-interferon alfa-2b
Biological/Vaccine: PEG-interferon alfa-2b Dose 1.5 mg/kg/week given subcutaneously EG-Intron

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Primary	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.	Every 2 -3 cycles (8 - 12 weeks)	Yes

External Links

•   UT MD Anderson Cancer Center Website