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Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Study of Gemcitabine in the Treatment of Patients With Metastatic Breast Cancer Previously Treated With Adriamycin and Taxol


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Violante E. Currie, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-030

NCT ID:

NCT00003540

Start Date:

June 1998

Completion Date:

November 2002

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021