Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 2/23/2019 |
| Start Date: | June 8, 2000 |
| End Date: | June 30, 2020 |
Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
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.
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.
- 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.
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
We found this trial at
9
sites
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11100 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
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