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Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003540
First received: November 1, 1999
Last updated: December 3, 2009
Last verified: December 2009
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel.


Condition Intervention Phase
Breast Cancer
 Drug: gemcitabine hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 30
Study Start Date: June 1998
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens, including doxorubicin and paclitaxel.
  • Characterize the nature of toxicity of gemcitabine in this patient population.
  • Determine the response duration to gemcitabine in this patient population.

OUTLINE: Patients receive gemcitabine IV over 30 minutes once weekly for 3 consecutive weeks (days 1, 8, and 15) followed by 1 week of rest. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 13 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic breast cancer

  • Bidimensionally measurable disease

    • No bone scan abnormalities alone
    • Lytic lesions in conjunction with bone scan abnormalities allowed
    • No pure blastic bone metastases
    • No pleural or peritoneal effusions
    • No previously irradiated lesions
  • Must have received 2-4 prior chemotherapy regimens, including paclitaxel and doxorubicin, for breast cancer

  • Brain metastases allowed if other measurable disease exists

    • No uncontrolled or life threatening brain lesions
  • No carcinomatous meningitis

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • AST/ALT no greater than 5 times upper limit of normal

Renal:

  • Calcium no greater than 11.0 mg/dL

Other:

  • Not pregnant
  • Negative pregnancy test
  • No history of other malignancy except carcinoma in situ of the cervix or curatively treated nonmelanoma skin cancer
  • No other serious medical illnesses, including severe infection and severe malnutrition

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior hormonal therapies for stage IV disease and/or adjuvant therapy allowed
  • At least 3 weeks since prior hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to greater than 30% of the marrow bearing bone
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to the only measurable lesion

Surgery:

  • Recovered from prior surgery
  • No concurrent surgery to the only measurable lesion

Other:

  • No concurrent nonprotocol treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003540

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Violante E. Currie, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00003540     History of Changes
Other Study ID Numbers: CDR0000066594, MSKCC-98030, NCI-G98-1474
Study First Received: November 1, 1999
Last Updated: December 3, 2009
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 22, 2013