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

NCT00006256 | Completed Phase 2 DMC

• 1 other identifier: CWRU2199
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 9

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• chemotherapy dose achieved during concurrent Taxol and radiation therapy.

  Followed every 3 months for 1 year

Secondary Outcomes (3)

• Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.

  1 year

• Pulmonary function

  1 year

• Survival

  5 years

Interventions

paclitaxel DRUG

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.

adjuvant therapy PROCEDURE

doxorubicin and cyclophosphamide adjuvant regimen

radiation therapy RADIATION

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (9)

UH-CantonMercy

Canton, Ohio, 44708, United States

Location

UH-Geauga

Chardon, Ohio, 44024, United States

Location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5055, United States

Location

UH-Monarch

Mayfield Heights, Ohio, 44124, United States

Location

UH-LUICC

Mentor, Ohio, 44060, United States

Location

UH-Southwest

Middleburg Heights, Ohio, 44130, United States

Location

UH-Chagrin Highlands

Orange, Ohio, 44122, United States

Location

UH-Green Road

South Euclid, Ohio, 44121, United States

Location

UH-Westlake

Westlake, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Janice Lyons, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: January 27, 2003
• Study Start: June 8, 2000
• Primary Completion: November 30, 2005
• Study Completion: November 20, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (9)