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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00110084 |
RATIONALE: Drugs used in chemotherapy, such as ABI-007 and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: gemcitabine hydrochloride Drug: paclitaxel albumin-stabilized nanoparticle formulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-Paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 43 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 or cytologically confirmed invasive breast cancer
Clinical evidence of metastatic disease
Measurable disease, defined as at least 1 measurable lesion
The following are considered non-measurable disease:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Vivek Roy, MD, FACP | Mayo Clinic |
Investigator: | Philip J. Stella, MD | CCOP - Michigan Cancer Research Consortium |
Study ID Numbers: | CDR0000423195, NCCTG-N0531 |
Study First Received: | May 3, 2005 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00110084 History of Changes |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IV breast cancer |
Antimetabolites Skin Diseases Immunologic Factors Breast Neoplasms Antimitotic Agents Antiviral Agents Immunosuppressive Agents |
Recurrence Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Gemcitabine Antineoplastic Agents, Phytogenic Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors Antimitotic Agents |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Paclitaxel Therapeutic Uses Tubulin Modulators Gemcitabine Antineoplastic Agents, Phytogenic Breast Diseases |