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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


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Optimal Biologic Dose at 8 weeks

Outcome 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.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Judith K. Wolf, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID02-115

NCT ID:

NCT00085384

Start Date:

July 2002

Completion Date:

April 2007

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • peritoneal cavity cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030