Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	CWRU-2199 BMS-CWRU-2199, NCI-G00-1851, NCT00006256

Objectives

1. 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.
2. Assess the cosmetic results of breast conservation after this treatment in these patients.
3. Determine the pulmonary toxicity of this regimen in these patients.

Entry Criteria

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

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

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

Expected Enrollment

Approximately 40 patients will be accrued for this study over 12-18 months.

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Beth Overmoyer, MD, FACP, Protocol chair		Ph: 216-844-8573 Email: bao4@po.cwru.edu

Registry Information
Official Title		Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
Trial Start Date		2000-06-08
Registered in ClinicalTrials.gov		NCT00006256
Date Submitted to PDQ		2000-08-01
Information Last Verified		2004-11-22
NCI Grant/Contract Number		P30-CA43703

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