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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006007 |
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 II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Pemetrexed disodium Pemetrexed |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer |
Study Start Date: | December 2000 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Bidimensionally measurable disease
No active CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
No more than 3 prior chemotherapy regimens including adjuvant therapy
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Show 24 Study Locations |
North Central Cancer Treatment Group |
National Cancer Institute (NCI) |
Study Chair: | Alex A. Adjei, MD, PhD | Mayo Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Ma CX, Steen P, Rowland KM, Niedringhaus RD, Fitch TR, Kugler JW, Hillman DW, Perez EA, Ingle JN, Adjei AA. A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: an NCCTG study. Ann Oncol. 2006 Feb;17(2):226-31. Epub 2005 Nov 22.
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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.
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Study ID Numbers: | CDR0000068015, NCCTG-983253 |
First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006007 |
Health Authority: | United States: Federal Government |
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