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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: gemcitabine hydrochloride

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Violante E. Currie, MD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 1998
• Primary Completion (Actual): November 1, 2002
• Study Completion (Actual): November 1, 2002

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: September 24, 2003
• First Posted (Estimate): September 25, 2003

Study Record Updates

• Last Update Posted (Estimate): June 26, 2013
• Last Update Submitted That Met QC Criteria: June 24, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: stage IV breast cancer; recurrent breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: 98-030; CDR0000066594 (Registry Identifier: PDQ (Physician Data Query)); NCI-G98-1474