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Status:

COMPLETED

Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cervical Cancer

Eligibility:

FEMALE

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how ...

Detailed Description

OBJECTIVES: * Determine the antitumor activity of pemetrexed disodium in patients with recurrent carcinoma of the cervix that failed higher priority treatment protocols. * Determine the nature and de...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed carcinoma of the cervix
  • Squamous cell or non-squamous cell
  • Recurrent disease
  • Progressive disease
  • Measurable disease
  • At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan
  • Tumors within a previously irradiated field are considered non-target lesions unless disease progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy
  • Not amenable to surgery, radiotherapy, or other therapy
  • Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or non-squamous cell carcinoma of the cervix
  • Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
  • PATIENT CHARACTERISTICS:
  • Age
  • Any age
  • Performance status
  • GOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Hepatic
  • AST and ALT ≤ 3 times upper limit of normal (ULN)\*
  • Alkaline phosphatase ≤ 3 times ULN\*
  • Bilirubin ≤ 1.5 times ULN NOTE: \* ≤ 5 times ULN if liver metastases are present
  • Renal
  • Creatinine clearance ≥ 45 mL/min
  • Other
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study participation
  • Neuropathy (sensory and motor) ≤ grade 1
  • No active infection requiring antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • At least 3 weeks since prior biologic or immunologic agents for the malignant tumor
  • At least 24 hours since prior growth factors
  • One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following:
  • Monoclonal antibodies
  • Cytokines
  • Small-molecule inhibitors of signal transduction
  • No concurrent routine colony-stimulating factors
  • Chemotherapy
  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • No more than 1 prior cytotoxic chemotherapy regimen with either single or combination cytotoxic drug therapy
  • No prior pemetrexed disodium
  • Endocrine therapy
  • At least 1 week since prior hormonal therapy for the malignant tumor
  • Concurrent hormone replacement therapy allowed
  • Radiotherapy
  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to \> 25% of bone marrow
  • Surgery
  • Recovered from prior surgery
  • Other
  • At least 3 weeks since other prior therapy for the malignant tumor
  • No nonsteroidal anti-inflammatory drugs for 2-5 days before, during, and for 1-2 days after study drug administration
  • Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed
  • No prior therapy that would contraindicate study participation

Exclusion

    Key Trial Info

    Start Date :

    August 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00087113

    Start Date

    August 1 2004

    Last Update

    February 14 2014

    Active Locations (22)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (22 locations)

    1

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    2

    Doctors Medical Center

    Modesto, California, United States, 95350-4138

    3

    Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, United States, 06105

    4

    Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, United States, 60521