This trial is active, not recruiting.

Condition breast cancer
Treatments paclitaxel, adjuvant therapy, radiation therapy
Phase phase 2
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 2000
End date November 2005
Trial size 44 participants
Trial identifier NCT00006256, CWRU-2199, CWRU2199, NCI-2010-01058, NCI-G00-1851, P30CA043703


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: This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Determine the feasibility of concurrent paclitaxel and breast radiotherapy
time frame: Followed every 3 months for 1 year

Secondary Outcomes

Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.
time frame: 1 year
Pulmonary function
time frame: 1 year
time frame: 5 years

Eligibility Criteria

Female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Stage II or III invasive breast cancer - Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required - No prior contralateral breast cancer - No metastatic disease - Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy - Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks - Candidate for definitive radiotherapy - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm3 - Granulocyte count at least 2,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT/AST no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No concurrent poorly controlled ischemic heart disease or congestive heart failure - LVEF at least 45% by MUGA scan or echocardiogram Pulmonary: - No concurrent severe chronic obstructive or restrictive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No concurrent severe medical or psychiatric illness - No concurrent severe diabetes mellitus - No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) Chemotherapy: - See Disease Characteristics - Prior tamoxifen allowed - No concurrent tamoxifen Endocrine therapy: - Not specified Radiotherapy: - No prior radiation to the breast Surgery: - Recovered form prior surgery Other: - No concurrent adjuvant therapy on another clinical trial

Additional Information

Official title Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
Description OBJECTIVES: - Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy. - Assess the cosmetic results of breast conservation after this treatment in these patients. - Determine the pulmonary toxicity of this regimen in these patients. 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.