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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003540

98-030

NCI-G98-1474

CDR0000066594 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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