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

NCT ID: NCT00003540

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30
• Study Completion Date: 2002-11-30

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Violante E. Currie, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000066594

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G98-1474

Identifier Type: -

Identifier Source: secondary_id

98-030

Identifier Type: -

Identifier Source: org_study_id