Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
18 Years
N/A
Female
Breast Cancer
Trial Information
Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the feasibility of concurrent paclitaxel and breast radiotherapy
Outcome Description:
Ability to deliver appropriate doses of radiation therapy within the appropriate time course and calculate the chemotherapy dose achieved during concurrent Taxol and radiation therapy.
Outcome Time Frame:
Followed every 3 months for 1 year
Safety Issue:
Yes
Principal Investigator
Paula Silverman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU2199
NCT ID:
NCT00006256
Start Date:
June 2000
Completion Date:
November 2015
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| UH-CantonMercy | Canton, Ohio 44708 |
| UH-Geauga | Chardon, Ohio 44024 |
| UH-Monarch | Mayfield Heights, Ohio 44124 |
| UH-LUICC | Mentor, Ohio 44060 |
| UH-Southwest | Middleburgh Heights, Ohio 44130 |
| UH-Chagrin Highlands | Orange Village, Ohio 44122 |
| UH-Green Road | South Euclid, Ohio 44121 |
| UH-Westlake | Westlake, Ohio 44145 |
