Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer

Case Comprehensive Cancer Center44 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

paclitaxelDRUG

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.

adjuvant therapyPROCEDURE

doxorubicin and cyclophosphamide adjuvant regimen

radiation therapyRADIATION

Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (9)

UH-CantonMercy

Canton, Ohio, United States

UH-Geauga

Chardon, Ohio, United States

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

UH-Monarch

Mayfield Heights, Ohio, United States

Outcomes

Primary Outcomes

Determine the feasibility of concurrent paclitaxel and breast radiotherapy

Ability to deliver appropriate doses of radiation therapy within the appropriate time course

Time frame: Followed every 3 months for 1 year

chemotherapy dose achieved during concurrent Taxol and radiation therapy.

Time frame: Followed every 3 months for 1 year

Secondary Outcomes

Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.

These parameters will be assessed by medical and radiation oncology. We expect at least a \> 60% completion rate with this treatment, which translates into confidence limits of 46% to 74% when 40 patients are investigated.

Time frame: 1 year

Pulmonary function

Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).

Time frame: 1 year

Survival

Patients followed for long term survival for at least 5 years.

Time frame: 5 years

Data from ClinicalTrials.gov

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