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LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 5, 2000
Last updated: July 23, 2008
Last verified: May 2006

July 5, 2000
July 23, 2008
December 2000
May 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006007 on Archive Site
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LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.


  • Assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in the treatment of women with metastatic breast cancer who have received an anthracycline and a taxane in the adjuvant and/or metastatic setting and no more than 1 chemotherapy regimen for metastatic disease (unless these were a taxane and anthracycline).
  • Determine the toxicity of this regimen in this patient population.
  • Determine time to progression and overall survival of these patients receiving this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. pemetrexed disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8. Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response receive 2 additional courses.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.

Phase 2
Primary Purpose: Treatment
Breast Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: pemetrexed disodium
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2008   (final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed breast cancer with clinical evidence of metastatic disease
  • Bidimensionally measurable disease

    • If bisphosphonates used, must have measurable disease site other than bone
    • No bone only disease
  • Must have received a prior anthracycline and taxane in the adjuvant and/or metastatic setting
  • No clinically significant pericardial effusions, pleural effusions, or ascites unless they can be drained
  • No active CNS metastases

    • Treated CNS metastasis that has ben stable for at least 8 weeks allowed
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN (5 times ULN if liver metastases)
  • Albumin at least 3.0 g/dL


  • Creatinine clearance at least 45 mL/min


  • No New York Heart Association class III or IV heart disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to take folic acid and cyanocobalamin (vitamin B12) supplements
  • Body surface area less than 3 m^2
  • No uncontrolled infection
  • No chronic debilitating disease
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas


Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • At least 4 weeks since prior genetic therapy
  • No concurrent immunomodulating agents


  • See Disease Characteristics
  • No more than 3 prior chemotherapy regimens including adjuvant therapy

    • No more than 1 prior chemotherapy regimen for metastatic disease unless these were a taxane and anthracycline
  • At least 4 weeks since prior chemotherapy
  • No prior gemcitabine and/or pemetrexed disodium
  • No other concurrent cytostatic or cytotoxic chemotherapy

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to greater than 25% of bone marrow
  • No prior strontium chloride Sr 89
  • No concurrent radiotherapy


  • At least 4 weeks since prior major surgery


  • No aspirin or nonsteroidal antiinflammatory agents 2 days before, the day of, and for 2 days after pemetrexed disodium administration (5 days before for long acting agents such as naproxen, piroxicam, diflunisal, or nabumetone)
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
CDR0000068015, NCCTG-983253
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Alex A. Adjei, MD, PhD Mayo Clinic
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP