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

Breast Cancer Clinical Trial

Official title:

Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006256
• Other study ID #: CWRU2199
• Status: Completed
• Phase: Phase 2
• Start date: June 8, 2000
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 20, 2023
• Est. primary completion date: November 30, 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	UH-CantonMercy	Canton	Ohio
United States	UH-Geauga	Chardon	Ohio
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	UH-Monarch	Mayfield Heights	Ohio
United States	UH-LUICC	Mentor	Ohio
United States	UH-Southwest	Middleburg Heights	Ohio
United States	UH-Chagrin Highlands	Orange Village	Ohio
United States	UH-Green Road	South Euclid	Ohio
United States	UH-Westlake	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the feasibility of concurrent paclitaxel and breast radiotherapy	Ability to deliver appropriate doses of radiation therapy within the appropriate time course	Followed every 3 months for 1 year
Primary	chemotherapy dose achieved during concurrent Taxol and radiation therapy.		Followed every 3 months for 1 year
Secondary	Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.	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.	1 year
Secondary	Pulmonary function	Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).	1 year
Secondary	Survival	Patients followed for long term survival for at least 5 years.	5 years