Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer
N/A
60 Years
Both
Breast Cancer
Trial Information
Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer
OBJECTIVES:
- Compare the toxic effects of doxorubicin, cyclophosphamide, and paclitaxel vs
cyclophosphamide, thiotepa, and carboplatin in patients with high-risk primary breast
cancer. (Arm I closed to accural as of 4/6/2006.)
- Compare the efficacies of these regimens followed by peripheral blood stem cell rescue
in these patients.
- Determine the efficacy of a bisphosphonate to prevent relapse/metastasis after
high-dose chemotherapy in these patients.
OUTLINE: This is a randomized study. Patients are stratified by stage of disease.
Peripheral blood stem cells (PBSC) are collected after mobilization with filgrastim (G-CSF),
administered subcutaneously or IV, twice daily beginning 3 days before collection and
continuing until collection is complete.
All patients receive conventional-dose adjuvant chemotherapy, probably comprising
doxorubicin IV, cyclophosphamide IV, and fluorouracil IV over 1 hour on days 1, 22, 43, and
64. Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy.
(Arm I closed to accrual as of 4/6/2006.)
- Arm I (ACT) (closed to accrual as of 4/6/2006): Patients receive doxorubicin IV over 24
hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV
over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered
beginning on day 0 and continuing until blood counts recover.
- Arm II (STAMP V): Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV
over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm
I.
Within 4-6 weeks of day 0 of high-dose chemotherapy, patients with estrogen and/or
progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years.
Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4
weeks for 2 years.
Quality of life is assessed before therapy, at 30 days after high-dose chemotherapy, and at
6 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for at least 10
years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven high-risk primary breast cancer with less than 60% chance of
progression-free survival of 3 years from diagnosis
- Stage II with at least 10 positive axillary nodes OR
- Stage IIIA or IIIB
- No histologically proven bone marrow metastasis
- No CNS metastasis
- Hormone receptor status:
- Hormone receptor status known
PATIENT CHARACTERISTICS:
Age:
- Physiological age 60 or under
Menopausal status:
- Not specified
Performance status:
- Karnofsky 80-100%
Life expectancy:
- See Disease Characteristics
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT or SGPT no greater than 2 times upper limit of normal
- Hepatitis B antigen negative
Renal:
- Creatinine no greater than 1.2 mg/dL
- Creatinine clearance at least 70 mL/min
- No prior hemorrhagic cystitis
Cardiovascular:
- Ejection fraction at least 55% by MUGA
- No prior significant valvular heart disease or arrhythmia
Pulmonary:
- FEV_1 at least 60% of predicted
- pO_2 at least 85 mm Hg on room air
- pCO_2 at least 43 mm Hg on room air
- DLCO at least 60% lower limit of predicted
Other:
- No other prior malignancy except squamous cell or basal cell skin cancer or stage I
or carcinoma in situ of the cervix
- No CNS dysfunction that would preclude compliance
- HIV negative
- No sensitivity to E. coli-derived products
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No prior doxorubicin of total dose exceeding 240 mg/m^2
- No prior paclitaxel of total dose of at least 750 mg/m^2
- No more than 12 months since prior conventional-dose adjuvant chemotherapy
Endocrine therapy:
- At least 4 weeks since prior hormonal therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No prior radiation to the left chest wall
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival
Safety Issue:
No
Principal Investigator
George Somlo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Federal Government
Study ID:
98096
NCT ID:
NCT00004092
Start Date:
May 1999
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Banner Good Samaritan Medical Center | Phoenix, Arizona 85006 |
