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Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005991
First Posted: February 25, 2004
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
July 5, 2000
February 25, 2004
October 10, 2012
April 2000
February 2003   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00005991 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
Phase I/II Study of Gemcitabine and Doxil Combination Chemotherapy in Patients With Advanced Solid Tumors (Phase I)/Breast Cancer (Phase II)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine and liposomal doxorubicin in treating women who have metastatic breast cancer.

OBJECTIVES:

I. Determine the objective response rate, duration of response, time to disease progression, and duration of survival of women with metastatic breast cancer when treated with gemcitabine and doxorubicin HCl liposome.

II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive gemcitabine intravenous (IV) over 30 minutes on days 1 and 8 and doxorubicin HCl liposome IV over 2.5 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 20 months.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: pegylated liposomal doxorubicin hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
February 2003
February 2003   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally measurable disease No uncontrolled brain metastases or leptomeningeal disease Brain metastases treated with surgery and/or radiotherapy allowed if neurologic status is stable two weeks after last dose of dexamethasone Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 8 g/dL Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.2 mg/dL SGPT less than 1.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF at least 50% by MUGA No cardiac disease or congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent serious illness, psychiatric disorder, or active infection No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior high-dose chemotherapy followed by bone marrow transplantation Chemotherapy: See Biologic Therapy At least 3 weeks since prior chemotherapy and recovered No prior doxorubicin HCl liposome or gemcitabine Prior neoadjuvant chemotherapy allowed At least 12 months since prior adjuvant anthracycline-based therapy and no evidence of anthracycline resistance (i.e., developed progressive disease while receiving adjuvant therapy or within 6 months of completing adjuvant therapy) Prior mitoxantrone allowed if total dose was no greater than 105 mg/m2 IV bolus or 140 mg/m2 IV continuous infusion Prior doxorubicin allowed if total dose was no greater than 300 mg/m2 IV bolus or 400 mg/m2 IV continuous infusion No prior chemotherapy for metastatic disease Endocrine therapy: Prior adjuvant and/or palliative hormonal therapy allowed Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Prior surgery allowed Other: At least 3 weeks since prior investigational study Concurrent pamidronate allowed if bone not the only site of disease

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00005991
CDR0000067980
MDA-DM-97127
NCI-1650
DM97-127 ( Other Identifier: UT MD Anderson Cancer Center )
No
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Edgardo Rivera, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP