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A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With 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

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

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.

Inclusion Criteria


- 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

- 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)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Alex A. Adjei, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

December 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Altru Health Systems Grand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Mayo Clinic Jacksonville, Florida  32224
Medcenter One Health System Bismarck, North Dakota  58501
CentraCare Health Plaza Saint Cloud, Minnesota  56303
Illinois Oncology Research Association Peoria, Illinois  61602