A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (TIME) Followed by Autologous Stem Cell Rescue in Metastatic Breast Cancer
18 Years
64 Years
Female
Breast Cancer
Trial Information
A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (TIME) Followed by Autologous Stem Cell Rescue in Metastatic Breast Cancer
OBJECTIVES: I. Evaluate the efficacy and toxicity of high dose topotecan with ifosfamide and
etoposide followed by autologous peripheral blood stem cell rescue in women with metastatic
breast cancer. II. Evaluate the response rates, progression free survival, engraftment, and
nonrelapse related mortality in women treated with this regimen. III. Evaluate the
pharmacokinetic profile of high dose topotecan with respect to the efficacy and toxicity of
ifosfamide and etoposide in these women.
OUTLINE: Peripheral blood stem cells (PBSC) are harvested from the patient and stored.
Patients receive ifosfamide IV over 2 hours and topotecan IV over 30 minutes on days -8 to
-6, and etoposide IV daily over 24 hours on days -5 to -3. Autologous PBSC are reinfused on
day 0. Patients are followed at 1, 3, 6, and 12 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study over 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer that has
demonstrated at least partial response to any salvage regimen Partial response defined as
at least 50% reduction in measurable or evaluable disease for at least 4 weeks, no disease
progression, no new lesions, or bone lesions that remain static for at least 8 weeks with
an improvement in pain symptoms No more than 3 organs involved with metastatic disease No
prior or active CNS involvement Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to 64 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 or 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 severe cardiac
dysfunction Ejection fraction at least 50% by MUGA No major heart disease Controlled
hypertension allowed Pulmonary: DLCO at least 50% of normal OR No symptomatic obstructive
or restrictive disease Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective barrier contraception No uncontrolled insulin dependent
diabetes mellitus No uncompensated major thyroid or adrenal dysfunction No significant
skin breakdown from tumor or other disease No other prior malignancy in past 5 years
except nonmelanoma skin cancer or carcinoma in situ of the cervix No active infections HIV
negative
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No more than 2 prior salvage regimens for metastatic disease No prior
topotecan Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified Other: No concurrent nitroglycerin preparations for angina No concurrent
antiarrhythmics for major ventricular arrhythmias
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Karen K. Fields, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Institutional Review Board
Study ID:
MCC-12220
NCT ID:
NCT00006032
Start Date:
March 2000
Completion Date:
April 2001
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
