Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer

NCT00002998 | Completed Phase 2

• 2 other identifiers: NCCTG-963251CDR0000065548
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 20

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  Up to 5 years

Secondary Outcomes (2)

• time to progression

  Up to 5 years

• survival

  Up to 5 years

Study Arms (1)

gemcitabine + cisplatin

EXPERIMENTAL

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.

Drug: cisplatin; Drug: gemcitabine hydrochloride

Interventions

cisplatin DRUG

gemcitabine + cisplatin

gemcitabine hydrochloride DRUG

gemcitabine + cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (20)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 10309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Geisinger Clinical and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57105-1080, United States

Location

Saskatchewan Cancer Agency

Regina, Saskatchewan, S4S 6X3, Canada

Location

Related Publications (1)

• 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.

  PMID: 15803016 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Patrick A. Burch, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 19, 2004
• Study Start: August 1, 1997
• Primary Completion: April 1, 2005
• Study Completion: May 1, 2006
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (19); CA (1)