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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

December 7, 2001
December 17, 2013
December 2001
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Complete list of historical versions of study NCT00027989 on ClinicalTrials.gov Archive Site
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Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Breast Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: pegylated liposomal doxorubicin hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00027989
CDR0000069104, PHARMATECH-P01-00002008, ORTHO-PHARMATECH-P01-000020008, PHARMATECH-20002183
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Pharmatech Oncology
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Study Chair: Sandy Marcus Pharmatech Oncology
National Cancer Institute (NCI)
April 2004

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