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Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
This study is ongoing, but not recruiting participants.
Study NCT00006256   Information provided by National Cancer Institute (NCI)
First Received: September 11, 2000   Last Updated: February 6, 2009   History of Changes

September 11, 2000
February 6, 2009
June 2000
 
 
 
Complete list of historical versions of study NCT00006256 on ClinicalTrials.gov Archive Site
 
 
 
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
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: Phase II trial to study the effectiveness of paclitaxel and radiation therapy in treating women who have stage II or stage III breast cancer.

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.

Phase II
Interventional
Treatment
Breast Cancer
  • Drug: paclitaxel
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006256
 
CDR0000068189, CWRU-2199, BMS-CWRU-2199, NCI-G00-1851
Ireland Cancer Center
National Cancer Institute (NCI)
Study Chair: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center
National Cancer Institute (NCI)
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP