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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00006256

Collaborator

(none)

Enrollment

Locations

266.8

Duration (Months)

4.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

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

Study Start Date :

Jun 8, 2000

Actual Primary Completion Date :

Nov 30, 2005

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

Determine the feasibility of concurrent paclitaxel and breast radiotherapy [Followed every 3 months for 1 year]
Ability to deliver appropriate doses of radiation therapy within the appropriate time course
chemotherapy dose achieved during concurrent Taxol and radiation therapy. [Followed every 3 months for 1 year]

Secondary Outcome Measures

Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor. [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 [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 [5 years]
Patients followed for long term survival for at least 5 years.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UH-CantonMercy	Canton	Ohio	United States	44708
2	UH-Geauga	Chardon	Ohio	United States	44024
3	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5055
4	UH-Monarch	Mayfield Heights	Ohio	United States	44124
5	UH-LUICC	Mentor	Ohio	United States	44060
6	UH-Southwest	Middleburg Heights	Ohio	United States	44130
7	UH-Chagrin Highlands	Orange Village	Ohio	United States	44122
8	UH-Green Road	South Euclid	Ohio	United States	44121
9	UH-Westlake	Westlake	Ohio	United States	44145