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

NCT ID: NCT00006256

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-08
• Study Completion Date: 2023-11-20

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.

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

adjuvant therapy

doxorubicin and cyclophosphamide adjuvant regimen

Intervention Type: PROCEDURE

radiation therapy

Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janice Lyons, MD

Role: STUDY_CHAIR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

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, Ohio, United States

UH-Green Road

South Euclid, Ohio, United States

UH-Westlake

Westlake, Ohio, United States

Countries

United States

Other Identifiers

CWRU2199

Identifier Type: -

Identifier Source: org_study_id