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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006256 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel and radiation therapy in treating women who have stage II or stage III breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy |
| Enrollment: | 44 |
| Study Start Date: | June 2000 |
| Estimated Study Completion Date: | November 2015 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Ohio | |
| UH-CantonMercy | |
| Canton, Ohio, United States, 44708 | |
| UH-Geauga | |
| Chardon, Ohio, United States, 44024 | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5055 | |
| UH-Monarch | |
| Mayfield Heights, Ohio, United States, 44124 | |
| UH-LUICC | |
| Mentor, Ohio, United States, 44060 | |
| UH-Southwest | |
| Middleburgh Heights, Ohio, United States, 44130 | |
| UH-Chagrin Highlands | |
| Orange Village, Ohio, United States, 44122 | |
| UH-Green Road | |
| South Euclid, Ohio, United States, 44121 | |
| UH-Westlake | |
| Westlake, Ohio, United States, 44145 | |
| Study Chair: | Paula Silverman, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Paula Silverman, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006256 History of Changes |
| Other Study ID Numbers: | CWRU2199, P30CA043703, CWRU-2199, NCI-G00-1851 |
| Study First Received: | September 11, 2000 |
| Last Updated: | June 13, 2011 |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Paclitaxel Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |