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Status:

COMPLETED

Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Lead Sponsor:

Gynecologic Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cervical Cancer

Eligibility:

FEMALE

Up to 120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growt...

Detailed Description

OBJECTIVES: Primary * To estimate the antitumor activity of pemetrexed disodium and cisplatin with objective tumor response (partial and complete response) in patients with advanced, persistent, or ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed squamous or nonsquamous cell carcinoma of the cervix
  • Advanced, persistent, or recurrent disease
  • Disease not amenable to curative therapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have ≥ 1 target lesion to be used to assess response
  • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy
  • PATIENT CHARACTERISTICS:
  • GOG performance status 0-2
  • Platelet count ≥ 100,000/mm\^3
  • ANC ≥ 1,500/mm\^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 60 mL/min
  • SGOT ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if due to hepatic metastases)
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Neuropathy (sensory and motor) ≤ grade 1
  • Able to take folic acid, vitamin B12, and dexamethasone according to study protocol
  • No history of other invasive malignancies within the past 5 years, except nonmelanoma skin cancer
  • No active infection requiring antibiotics with the exception of uncomplicated UTI
  • No presence of third space fluid which cannot be controlled by drainage
  • PRIOR CONCURRENT THERAPY:
  • Recovered from effects of recent surgery, radiotherapy, or other therapy
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • At least 4 weeks since prior radiotherapy
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and patient remains free of recurrent or metastatic disease
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer
  • No prior radiotherapy to more than 25% of marrow-bearing areas
  • No prior cancer treatment that contraindicates study treatment
  • No prior cytotoxic drugs for advanced or recurrent carcinoma of the cervix
  • Prior cisplatin as a radiosensitizer for primary treatment of disease allowed
  • No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2-5 days before, during, or for 2 days after receiving pemetrexed disodium
  • No NSAIDS with a long half-life (e.g., naproxen, piroxicam, diflunisal, or nabumetone) 5 days before, during, and for 2 days after receiving pemetrexed disodium
  • Concurrent hormone replacement therapy is permitted
  • Concurrent daily low-dose acetylsalicylic acid therapy (≤ 325 mg/day) allowed
  • Concurrent use of acetylsalicylic acid (up to 1.3 g/day) allowed

Exclusion

    Key Trial Info

    Start Date :

    September 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2014

    Estimated Enrollment :

    55 Patients enrolled

    Trial Details

    Trial ID

    NCT00691301

    Start Date

    September 1 2008

    End Date

    July 1 2014

    Last Update

    January 9 2018

    Active Locations (12)

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

    Page 1 of 3 (12 locations)

    1

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    2

    Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, United States, 92868

    3

    University of Mississippi Cancer Clinic

    Jackson, Mississippi, United States, 39216

    4

    Women's Cancer Center - La Canada

    Las Vegas, Nevada, United States, 89169