Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00027989
First received: December 7, 2001
Last updated: December 17, 2013
Last verified: April 2004
  Purpose

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.


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00027989

Locations
United States, Alabama
Montgomery Cancer Center
Montgomery, Alabama, United States, 36106
United States, California
California Cancer Medical Center
West Covina, California, United States, 91790
United States, Colorado
Pharmatech Oncology
Denver, Colorado, United States, 80203
United States, Maryland
Oncology-Hematology Associates, P.A.
Clinton, Maryland, United States, 20735
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29201
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Pharmatech Oncology
Investigators
Study Chair: Sandy Marcus Pharmatech Oncology
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00027989     History of Changes
Other Study ID Numbers: CDR0000069104, PHARMATECH-P01-00002008, ORTHO-PHARMATECH-P01-000020008, PHARMATECH-20002183
Study First Received: December 7, 2001
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer

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

ClinicalTrials.gov processed this record on October 20, 2014