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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005991 |
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 |
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Breast Cancer |
Drug: gemcitabine hydrochloride Drug: pegylated liposomal doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | 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) |
Study Start Date: | April 2000 |
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 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Edgardo Rivera, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000067980, MDA-DM-97127, NCI-1650 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005991 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Antimetabolites Anti-Bacterial Agents Radiation-Sensitizing Agents Immunologic Factors Skin Diseases Breast Neoplasms |
Gemcitabine Immunosuppressive Agents Antiviral Agents Doxorubicin Breast Diseases Recurrence |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Antiviral Agents Doxorubicin Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine Breast Diseases |