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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.
First Received: September 11, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006256
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: paclitaxel
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006256

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5055
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068189, CWRU-2199, BMS-CWRU-2199, NCI-G00-1851
Study First Received: September 11, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006256     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:
Skin Diseases
Paclitaxel
Tubulin Modulators
Adjuvants, Immunologic
Breast Neoplasms
Antimitotic Agents
Cyclophosphamide
Antineoplastic Agents, Phytogenic
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009