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

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Primary Purpose

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

paclitaxel

adjuvant therapy

radiation therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

UH-CantonMercy
UH-Geauga
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
UH-Monarch
UH-LUICC
UH-Southwest
UH-Chagrin Highlands
UH-Green Road
UH-Westlake

Outcomes

Primary Outcome Measures

Determine the feasibility of concurrent paclitaxel and breast radiotherapy

Ability to deliver appropriate doses of radiation therapy within the appropriate time course

chemotherapy dose achieved during concurrent Taxol and radiation therapy.

Secondary Outcome Measures

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.

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).

Survival

Patients followed for long term survival for at least 5 years.

Full Information

NCT ID

NCT00006256

First Posted

September 11, 2000

Last Updated

July 12, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00006256

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 8, 2000 (undefined)

Primary Completion Date

November 30, 2005 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Description

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

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Description

doxorubicin and cyclophosphamide adjuvant regimen

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Determine the feasibility of concurrent paclitaxel and breast radiotherapy

Description

Ability to deliver appropriate doses of radiation therapy within the appropriate time course

Time Frame

Followed every 3 months for 1 year

Title

chemotherapy dose achieved during concurrent Taxol and radiation therapy.

Time Frame

Followed every 3 months for 1 year

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

1 year

Title

Pulmonary function

Description

Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).

Time Frame

1 year

Title

Survival

Description

Patients followed for long term survival for at least 5 years.

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janice Lyons, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

UH-CantonMercy

City

Canton

State/Province

Ohio

ZIP/Postal Code

44708

Country

United States

Facility Name

UH-Geauga

City

Chardon

State/Province

Ohio

ZIP/Postal Code

44024

Country

United States

Facility Name

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5055

Country

United States

Facility Name

UH-Monarch

City

Mayfield Heights

State/Province

Ohio

ZIP/Postal Code

44124

Country

United States

Facility Name

UH-LUICC

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

UH-Southwest

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

UH-Chagrin Highlands

City

Orange Village

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

UH-Green Road

City

South Euclid

State/Province

Ohio

ZIP/Postal Code

44121

Country

United States

Facility Name

UH-Westlake

City

Westlake

State/Province

Ohio

ZIP/Postal Code

44145

Country

United States

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial