Clinical trial NCT00006256: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Determine the feasibility of concurrent paclitaxel and breast radiotherapy
timeFrame: Followed every 3 months for 1 year
measure: chemotherapy dose achieved during concurrent Taxol and radiation therapy.
timeFrame: Followed every 3 months for 1 year
Secondary outcomes:
measure: Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.
timeFrame: 1 year
measure: Pulmonary function
timeFrame: 1 year
measure: Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Canton
country: United States
facility: UH-CantonMercy
state: Ohio
city: Chardon
country: United States
facility: UH-Geauga
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
city: Mayfield Heights
country: United States
facility: UH-Monarch
state: Ohio
city: Mentor
country: United States
facility: UH-LUICC
state: Ohio
city: Middleburg Heights
country: United States
facility: UH-Southwest
state: Ohio
city: Orange Village
country: United States
facility: UH-Chagrin Highlands
state: Ohio
city: South Euclid
country: United States
facility: UH-Green Road
state: Ohio
city: Westlake
country: United States
facility: UH-Westlake
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Janice Lyons, MD
role: STUDY_CHAIR
References: