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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003540
• Other study ID #: 98-030
• Secondary ID: CDR0000066594NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 24, 2013
• Start date: June 1998
• Est. completion date: November 2002

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,