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Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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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 CenterCleveland, Ohio  44106-5065
UH-CantonMercyCanton, Ohio  44708
UH-GeaugaChardon, Ohio  44024
UH-MonarchMayfield Heights, Ohio  44124
UH-LUICCMentor, Ohio  44060
UH-SouthwestMiddleburgh Heights, Ohio  44130
UH-Chagrin HighlandsOrange Village, Ohio  44122
UH-Green RoadSouth Euclid, Ohio  44121
UH-WestlakeWestlake, Ohio  44145