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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006256
First Posted: January 27, 2003
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
  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: 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.


Condition Intervention Phase
Breast Cancer Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine the feasibility of concurrent paclitaxel and breast radiotherapy [ Time Frame: Followed every 3 months for 1 year ]
    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.


Secondary Outcome Measures:
  • Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor. [ Time Frame: 1 year ]
    These parameters will be assessed by medical and radiation oncology. We expect at least a > 60% completion rate with this treatment, which translates into confidence limits of 46% to 74% when 40 patients are investigated.

  • Pulmonary function [ Time Frame: 1 year ]
    Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).

  • Survival [ Time Frame: 5 years ]
    Patients followed for long term survival for at least 5 years.


Enrollment: 44
Study Start Date: June 2000
Estimated Study Completion Date: August 2017
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: paclitaxel
    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.
    Procedure: adjuvant therapy
    doxorubicin and cyclophosphamide adjuvant regimen
    Radiation: radiation therapy
    Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006256


Locations
United States, Ohio
UH-CantonMercy
Canton, Ohio, United States, 44708
UH-Geauga
Chardon, Ohio, United States, 44024
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5055
UH-Monarch
Mayfield Heights, Ohio, United States, 44124
UH-LUICC
Mentor, Ohio, United States, 44060
UH-Southwest
Middleburgh Heights, Ohio, United States, 44130
UH-Chagrin Highlands
Orange Village, Ohio, United States, 44122
UH-Green Road
South Euclid, Ohio, United States, 44121
UH-Westlake
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Paula Silverman, MD Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00006256     History of Changes
Other Study ID Numbers: CWRU2199
P30CA043703 ( U.S. NIH Grant/Contract )
CWRU-2199 ( Other Identifier: Case Comprehensive Cancer Center )
NCI-G00-1851
NCI-2010-01058 ( Registry Identifier: CTRP )
First Submitted: September 11, 2000
First Posted: January 27, 2003
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by Case Comprehensive Cancer Center:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action