Status:
COMPLETED
Paclitaxel and Radiation Therapy in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy us...
Detailed Description
OBJECTIVES: Primary * Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by pathologic response rates) in patients with stage II or III breast cancer. Secondary * Evaluat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically documented invasive carcinoma of the breast\*
- Tumor ≥ 2 cm in greatest dimension (e.g., T2-4) and any nodal status (e.g., N0-3), including locally advanced disease, as defined by the following criteria:
- Primary tumor ≥ 5 cm
- Tumor of any size with direct extension to the chest wall or skin
- Inflammatory breast cancer (T4d)
- Metastasis to ipsilateral internal mammary node
- Ipsilateral lymph nodes that are clinically fixed to each other or to other structures (N2) NOTE: \*Diagnosis may be made by core or tru-cut biopsies
- Measurable or evaluable tumor
- Measurable disease is defined as any mass that can be reproducibly measured in two perpendicular dimensions
- Evaluable disease is defined as any lesion visible by mammogram or palpable by physical exam that does not fit the above criteria of measurability
- Planning to undergo breast conservation surgery
- Willing to undergo AND is a candidate for radiotherapy, in the judgement of the treating radiation oncologist
- No evidence of distant metastatic disease (e.g., lung, liver, bone, brain)
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- WBC ≥ 3,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Left ventricular ejection fraction ≥ 45%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancies within the past 5 years, except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
- No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
- No serious medical illness that, in the judgment of the treating physician, places the patient at risk
- No peripheral neuropathy ≥ grade 2
- PRIOR CONCURRENT THERAPY:
- Prior tamoxifen as chemoprevention allowed
- No prior radiotherapy to the ipsilateral breast
- Prior radiotherapy to the contralateral breast is allowed
- No prior chemotherapy
Exclusion
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00647218
Start Date
February 1 2000
End Date
November 1 2004
Last Update
February 23 2017
Active Locations (6)
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1
Williamson Medical Center
Frankling, Tennessee, United States, 37067
2
Jackson-Madison Hospital
Jackson, Tennessee, United States, 38301
3
Boston Baskin Cancer Center
Memphis, Tennessee, United States, 38104
4
Methodist Lebonheur Healthcare
Memphis, Tennessee, United States, 38104