Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00006256
First received: September 11, 2000
Last updated: July 17, 2014
Last verified: July 2014
  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: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Patients followed for long term survival for at least 5 years.


Enrollment: 44
Study Start Date: June 2000
Estimated Study Completion Date: November 2015
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006256

Locations
United States, Ohio
UH-CantonMercy
Canton, Ohio, United States, 44708
UH-Geauga
Chardon, Ohio, United States, 44024
Case 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
Investigators
Study Chair: Paula Silverman, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00006256     History of Changes
Other Study ID Numbers: CWRU2199, P30CA043703, CWRU-2199, NCI-G00-1851, NCI-2010-01058
Study First Received: September 11, 2000
Last Updated: July 17, 2014
Health Authority: United States: Federal Government

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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014