Radiation Therapy Plus Paclitaxel in Treating Patients With Stage IIB or Stage III Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00003050
First received: November 1, 1999
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients with stage IIB or stage III breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: tamoxifen citrate
Procedure: surgical procedure
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Weekly Paclitaxel During Radiation Therapy for Locally Advanced Breat Cancer

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Enrollment: 46
Study Start Date: April 1997
Study Completion Date: March 2000
Primary Completion Date: March 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the safety and feasibility of twice a week paclitaxel and radiation therapy in patients with locally advanced breast cancer. II. Determine the pathological effects of paclitaxel and radiation in locally advanced breast cancer.

OUTLINE: This is a nonrandomized, dual institution study. Patients receive paclitaxel IV over 1 hour twice a week for a total of 8 weeks. This is started within 1 week of a tumor biopsy. Patients receive radiotherapy 5 days/week for 5.0 weeks within 1 week of the first paclitaxel dose. Operable patients who have progressive disease with the above therapy undergo a modified radical mastectomy (MRM), then receive 4 courses of doxorubicin IV and cyclophosphamide IV, administered once every 21 days. Inoperable patients receive this same chemotherapy regimen, then are reevaluated for surgery. Patients who have stable disease or who respond to the paclitaxel/radiation regimen undergo a MRM, then receive 4 courses of doxorubicin IV and paclitaxel IV (over 3 hours) once every 21 days. All patients with hormone receptor positive tumors receive tamoxifen for 5 years after all other therapy is completed.

PROJECTED ACCRUAL: A total of 40 patients (20 patients per institution) will be accrued over 18- 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven, untreated, locally advanced breast cancer; stage IIB (T3 N0), IIIA, or IIIB Measurable disease Not inflammatory breast cancer or other stage IIB (T2 N1) No distant metastases except for positive ipsilateral supraclavicular nodes

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception during and 6 months after treatment Medically and psychologically stable

PRIOR CONCURRENT THERAPY: No prior therapy of any type

  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: NCT00003050

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
University of Southern California
Investigators
Study Chair: Darcy V. Spicer, MD University of Southern California
  More Information

Additional Information:
Publications:
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00003050     History of Changes
Other Study ID Numbers: CDR0000065692 (1B-97-2), LAC-USC-1B972, NCI-G97-1304
Study First Received: November 1, 1999
Last Updated: May 20, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Tamoxifen
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014