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

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.

Condition Intervention Phase
Breast Cancer
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer

Resource links provided by NLM:

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

Study Start Date: December 2000
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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)
  Contacts and Locations
Please refer to this study by its identifier: NCT00006007

  Show 24 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Study Chair: Alex A. Adjei, MD, PhD Mayo Clinic
  More Information

Additional Information:
Ma CX, Steen P, Rowland KM, et al.: A phase II study of a combination of pemetrexed (Pem) and gemcitabine (Gem) in patients with metastatic breast cancer (MBC): an NCCTG study. [Abstract] J Clin Oncol 22 (Suppl 14): A-639, 36s, 2004. Identifier: NCT00006007     History of Changes
Other Study ID Numbers: CDR0000068015, NCCTG-983253
Study First Received: July 5, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists processed this record on April 17, 2014