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Phase II Study of Gemcitabine (GEMZAR) and Cisplatin (CDDP) in Advanced Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Phase II Study of Gemcitabine (GEMZAR) and Cisplatin (CDDP) in Advanced Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrick A. Burch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000065548

NCT ID:

NCT00002998

Start Date:

August 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080