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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:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003540
First received: November 1, 1999
Last updated: June 24, 2013
Last verified: June 2013

November 1, 1999
June 24, 2013
June 1998
November 2002   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003540 on ClinicalTrials.gov Archive Site
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Not Provided
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Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Breast Cancer
Drug: gemcitabine hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2002
November 2002   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003540
98-030, CDR0000066594, NCI-G98-1474
Not Provided
Not Provided
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Violante E. Currie, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP