Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00087100
First received: July 8, 2004
Last updated: February 12, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

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

Estimated Enrollment: 51
Study Start Date: May 2006
Primary Completion Date: August 2007 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00087100     History of Changes
Other Study ID Numbers: GOG-0129O, LILLY-H3E-US-JMGT, CDR0000372921
Study First Received: July 8, 2004
Last Updated: February 12, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Gynecologic Oncology Group:
recurrent endometrial carcinoma
endometrial adenocarcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

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

ClinicalTrials.gov processed this record on October 20, 2014