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Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix

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ClinicalTrials.gov Identifier: NCT00087113
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : February 14, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

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 well pemetrexed disodium works in treating patients with recurrent cancer of the cervix.


Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: pemetrexed disodium Phase 2

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 degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 1-2 years.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix
Study Start Date : August 2004
Actual Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Antitumor activity
  2. Toxicity


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087113


Locations
Show Show 22 study locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: David S. Miller, MD Simmons Cancer Center
Publications of Results:
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00087113    
Other Study ID Numbers: GOG-0127T
LILLY-H3E-US-JMGS
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014
Keywords provided by GOG Foundation ( Gynecologic Oncology Group ):
cervical squamous cell carcinoma
recurrent cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors