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A Phase II Study of Cyclophosphamide, Thiotepa, and Carboplatin (CTC) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Breast Cancer


Phase 2
15 Years
64 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase II Study of Cyclophosphamide, Thiotepa, and Carboplatin (CTC) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Breast Cancer


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

relapse-free survival

Outcome Description:

relapse free survival determined by the Kaplan-Meier product-limit method

Outcome Time Frame:

five years post transplant

Safety Issue:

No

Principal Investigator

Claudio Anasetti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Moffitt Cancer Center

Authority:

United States: Federal Government

Study ID:

MCC-11072

NCT ID:

NCT00005798

Start Date:

July 1995

Completion Date:

July 2007

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • inflammatory breast cancer
  • Breast Neoplasms

Name

Location
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Halifax Medical Center Daytona Beach, Florida  32114
Florida Cancer Specialists Fort Myers, Florida  33901