Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

NCT ID: NCT00005798

Last Updated: 2012-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-07-31
• Study Completion Date: 2007-07-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating women who have breast cancer.

Detailed Description

OBJECTIVES: I. Determine long term remission rates as measured by disease free survival in women with breast cancer treated with cyclophosphamide, thiotepa, and carboplatin followed by autologous hematopoietic stem cell transplantation. II. Determine the safety and efficacy of this combination chemotherapy regimen in this patient population.

OUTLINE: Peripheral blood stem cells (PBSC) are collected. Patients sequentially receive cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on days -6 to -4. PBSC are reinfused on day 0. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: At least 40 patients with 4-9 positive lymph nodes and at least 50 patients with 10 positive lymph nodes will be accrued for this study.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; inflammatory breast cancer

Study Design

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

Study Groups

CTC Conditioning Regimen

Cyclophosphamide Thiotepa Carboplatin

Group Type: OTHER

Carboplatin

Intervention Type: DRUG

Carboplatin will be given at a dose of 267 mg/m2 in D5 W IV over one hour daily on days -6, -5, and -4. (Total dose 800 mg/m2)

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be given at a dose of 2000 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 6000 mg/m2)

Thiotepa

Intervention Type: DRUG

Thiotepa will be given at a dose of 167 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 500 mg/m2 )

Interventions

Carboplatin

Carboplatin will be given at a dose of 267 mg/m2 in D5 W IV over one hour daily on days -6, -5, and -4. (Total dose 800 mg/m2)

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide will be given at a dose of 2000 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 6000 mg/m2)

Intervention Type: DRUG

Thiotepa

Thiotepa will be given at a dose of 167 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 500 mg/m2 )

Intervention Type: DRUG

Other Intervention Names

Paraplatin(R)

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Stage II with greater than 3 positive axillary lymph nodes following standard induction chemotherapy, as well as surgery and/or radiation as clinically indicated Stage III following standard induction chemotherapy with an anthracycline based regimen, and surgery and/or radiation as clinically indicated Inflammatory carcinoma following standard induction chemotherapy with an anthracycline based regimen, and surgery and/or radiation as clinically indicated Stage IV metastatic disease that has demonstrated a complete response to an anthracycline containing regimen, or no evidence of disease after surgery or radiation Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 64 and under Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal No history of severe hepatic dysfunction Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No evidence of severe cardiac dysfunction Ejection fraction at least 50% by MUGA No major heart disease Essential hypertension controlled with medications allowed Pulmonary: DLCO at least 50% of normal No symptomatic obstructive or restrictive pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No psychosocial disorder that would preclude study compliance No concurrent active infections No insulin dependent diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No significant skin breakdown from tumor or other disease HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior total dose of doxorubicin or daunorubicin less than 450 mg/m2 unless endometrial biopsy shows less than grade 2 drug effect Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent nitroglycerin preparations for angina pectoris No concurrent antiarrhythmic drugs for major ventricular dysrrhythmias

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Anasetti, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Halifax Medical Center

Daytona Beach, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

IRB-3898

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-G00-1760

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-11072

Identifier Type: -

Identifier Source: org_study_id