Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00027989
• Other study ID #: CDR0000069104
• Secondary ID: PHARMATECH-P01-0
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 7, 2001
• Last updated: December 17, 2013
• Start date: December 2001

Study information

• Verified date: April 2004
• Source: National Cancer Institute (NCI)
• 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 combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.

Description:

OBJECTIVES:

• Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine.

• Determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen.

• Determine the quality of life of patients treated with this regimen.

• Determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses beyond documentation of CR.

Quality of life is assessed at baseline, on day 1 of each course, and then at the end of study.

Patients are followed at 4 weeks and then every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• pegylated liposomal doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	Oncology-Hematology Associates, P.A.	Clinton	Maryland
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	Pharmatech Oncology	Denver	Colorado
United States	Montgomery Cancer Center	Montgomery	Alabama
United States	California Cancer Medical Center	West Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
Pharmatech Oncology

Country where clinical trial is conducted

United States,