Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: cisplatin
Drug: gemcitabine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
time to progression
Time Frame: Up to 5 years
Up to 5 years
survival
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Patrick A. Burch, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 16, 2004

First Posted (Estimate)

July 19, 2004

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-963251
  • CDR0000065548 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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