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Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
pegylated liposomal doxorubicin hydrochloride
Sponsored by
Pharmatech Oncology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Montgomery Cancer Center
  • California Cancer Medical Center
  • Pharmatech Oncology
  • Oncology-Hematology Associates, P.A.
  • South Carolina Oncology Associates
  • South Carolina Oncology Associates

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
December 17, 2013
Sponsor
Pharmatech Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00027989
Brief Title
Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Unknown status
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmatech Oncology

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy Marcus
Organizational Affiliation
Pharmatech Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
Montgomery Cancer Center
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
California Cancer Medical Center
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Pharmatech Oncology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80203
Country
United States
Facility Name
Oncology-Hematology Associates, P.A.
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States

12. IPD Sharing Statement

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Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

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