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Home > "L" Clinical Trials Conditions > LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer  LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Assess the antitumor activity of LY231514 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. LY231514 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 LY231514 - 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 LY231514 administration (5 days before for long acting agents such as naproxen, piroxicam, diflunisal, or nabumetone)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexAdjei, Study Chair, Mayo Clinic Cancer Center
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Additional Information:
Study ID Numbers: CDR0000068015; NCCTG-983253
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006007
Other Recurrent Breast Cancer Studies:
1. Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer
2. Bexarotene in Treating Patients With Metastatic Breast Cancer
3. Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
4. Erlotinib in Treating Women With Locally Advanced or Metastatic Breast Cancer
5. Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Louisiana Clinical Trials
Other New Orleans Clinical Trials
LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
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