Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer
NCT ID: NCT00002998
Last Updated: 2016-07-13
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
1997-08-31
2006-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy.
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Detailed Description
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OUTLINE: This is a nonrandomized study. Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, and 15 every 28 days. Patients with complete response may receive an additional 2 courses after attainment of complete response status. Treatment continues in the absence of disease progression or unacceptable toxicities for a maximum of 8 courses. Patients are followed every 3 months for 2 years and then at 3 years after treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gemcitabine + cisplatin
Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, and 15 every 28 days. Patients with complete response may receive an additional 2 courses after attainment of complete response status. Treatment continues in the absence of disease progression or unacceptable toxicities for a maximum of 8 courses. Patients are followed every 3 months for 2 years and then at 3 years after treatment.
cisplatin
gemcitabine hydrochloride
Interventions
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cisplatin
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3500/mm3 or absolute neutrophil count at least 2000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 0.3 mg/dL above upper limit of normal limit (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 0.3 mg/dL above ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: Physician-estimated oral caloric intake of at least 1200 calories per day No uncontrolled infection or chronic debilitating disease Not pregnant or nursing Women of childbearing potential must use adequate contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Must have previously received 1 but no more than 2 chemotherapy regimens At least 1 prior regimen administered for metastatic disease At least 1 prior regimen containing an anthracycline or paclitaxel At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior strontium 89 radiotherapy Prior radiotherapy must have been to less than 25% of bone marrow Surgery: At least 4 weeks since any major surgery
18 Years
ALL
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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Patrick A. Burch, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 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 Clinic
Saint Cloud, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Quain & Ramstad Clinic, P.C.
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 Clinical 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
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada
Countries
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References
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Burch PA, Mailliard JA, Hillman DW, Perez EA, Krook JE, Rowland KM, Veeder MH, Cannon MW, Ingle JN. Phase II study of gemcitabine plus cisplatin in patients with metastatic breast cancer: a North Central Cancer Treatment Group Trial. Am J Clin Oncol. 2005 Apr;28(2):195-200. doi: 10.1097/01.coc.0000144815.54746.d0.
Other Identifiers
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CDR0000065548
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-963251
Identifier Type: -
Identifier Source: org_study_id
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