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Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087100
  Purpose

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 persistent or recurrent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: pemetrexed disodium
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Pemetrexed disodium Pemetrexed
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 51
Study Start Date: May 2006
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of pemetrexed disodium in patients with persistent or recurrent endometrial adenocarcinoma 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 19-51 patients will be accrued for this study within 1-3.4 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial adenocarcinoma

    • Persistent or recurrent disease
  • Refractory to curative or standard therapy
  • 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 progression is documented or biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy
  • Must have received 1 prior chemotherapy regimen for endometrial cancer

    • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
  • 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
  • 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
  • At least 24 hours since prior growth factors
  • 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 directed at 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 directed at the malignant tumor
  • No nonsteroidal anti-inflammatory drugs 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087100

  Show 23 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: David S. Miller, MD Simmons Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000372921, GOG-0129O, LILLY-H3E-US-JMGT
Study First Received: July 8, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00087100  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma
endometrial adenocarcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer
Adenocarcinoma
Recurrence
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009