Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00005991
First received: July 5, 2000
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: gemcitabine hydrochloride
Drug: pegylated liposomal doxorubicin hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Gemcitabine and Doxil Combination Chemotherapy in Patients With Advanced Solid Tumors (Phase I)/Breast Cancer (Phase II)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 76
Study Start Date: April 2000
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005991

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Edgardo Rivera, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00005991     History of Changes
Other Study ID Numbers: CDR0000067980, MDA-DM-97127, NCI-1650, DM97-127
Study First Received: July 5, 2000
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Gemcitabine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 20, 2014