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

NCT00003540 | Completed Phase 2

• 3 other identifiers: 98-030CDR0000066594NCI-G98-1474
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Violante E. Currie, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 25, 2003
• Study Start: June 1, 1998
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

US (1)