Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

NCT00027989 | Unknown Phase 2

• 4 other identifiers: CDR0000069104PHARMATECH-P01-00002008ORTHO-PHARMATECH-P01-000020008PHARMATECH-20002183
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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 combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Interventions

gemcitabine hydrochloride DRUG

pegylated liposomal doxorubicin hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic breast cancer * Measurable disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL * Absolute neutrophil count at least 1,500/mm\^3 * No impaired bone marrow function Hepatic: * Bilirubin no greater than 2 mg/dL * AST and ALT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN (unless attributed to tumor) * No impaired hepatic function Renal: * Creatinine no greater than 2.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No impaired renal function Cardiovascular: * No prior cardiac disease within the past 5 years OR * LVEF at least 50% Other: * No prior uncontrolled seizures * No uncontrolled systemic infection * No anthracycline resistance * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior trastuzumab (Herceptin) Chemotherapy: * Prior adjuvant therapy with anthracycline of no more than 320 mg/m\^2 allowed Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to more than 1/3 of hematopoietic sites Surgery: * Not specified Other: * At least 30 days since prior investigational medications and recovered * No more than 1 prior treatment regimen for metastatic disease

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

Sponsors & Collaborators

• Pharmatech Oncology: lead

Study Sites (6)

Montgomery Cancer Center

Montgomery, Alabama, 36106, United States

Location

California Cancer Medical Center

West Covina, California, 91790, United States

Location

Pharmatech Oncology

Denver, Colorado, 80203, United States

Location

Oncology-Hematology Associates, P.A.

Clinton, Maryland, 20735, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29201, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29203, 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

• Sandy Marcus

  Pharmatech Oncology

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: December 1, 2001
• Last Updated: December 18, 2013

Record last verified: 2004-04

Locations

US (6)