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Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002998
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: May 2006
  Purpose

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 gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy.


Condition Intervention Phase
Breast Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine (GEMZAR) and Cisplatin (CDDP) in Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1997
Detailed Description:

OBJECTIVES: I. Assess the response rate of gemcitabine and cisplatin in the treatment of metastatic breast cancer in patients who have failed one or two systemic regimens. II. Determine time to progression and survival in these patients. III. Define further the toxicity of this two-drug combination in these patients.

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.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued into this study in approximately 9 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologic or cytologic confirmation of metastatic breast cancer with two exceptions: -New or enlarging pulmonary nodules demonstrable on two chest radiographs taken at least one month apart OR -Multiple characteristic lytic bone metastasis or liver metastases Measurable indicator lesion Measurable metastatic disease must be bidimensionally measurable except in the case of hepatomegaly that may be unidimensionally measurable Patients receiving bisphosphonates must have a measurable disease other than bone No CNS metastases unless controlled with prior surgery and/or radiotherapy

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002998

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 10309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic
Saint Cloud, Minnesota, United States, 56303
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, North Dakota
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States, 58501
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Altru Health Systems
Grand Forks, North Dakota, United States, 58201
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
Canada, Saskatchewan
Saskatchewan Cancer Agency
Regina, Saskatchewan, Canada, S4S 6X3
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Patrick A. Burch, MD Mayo Clinic
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002998     History of Changes
Other Study ID Numbers: CDR0000065548, NCCTG-963251
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cisplatin
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014