LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00006007
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2000-12-31
2008-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gemcitabine + pemetrexed
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.
gemcitabine hydrochloride
pemetrexed disodium
Interventions
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gemcitabine hydrochloride
pemetrexed disodium
Eligibility Criteria
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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 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
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* 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
Renal:
* Creatinine clearance at least 45 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Other:
* 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
* At least 4 weeks since prior genetic therapy
* No concurrent immunomodulating agents
Chemotherapy:
* 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
Radiotherapy:
* 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
Surgery:
* At least 4 weeks since prior major surgery
Other:
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Alex A. Adjei, MD, PhD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Health Plaza
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Medcenter One Health System
Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Altru Health Systems
Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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References
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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. doi: 10.1093/annonc/mdj054. Epub 2005 Nov 22.
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.
Other Identifiers
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NCI-2012-02348
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000068015
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-983253
Identifier Type: -
Identifier Source: org_study_id