Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer - Article Cancer Chemotherapy
Clinical Trial: Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
This study is currently recruiting patients.
PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.
|Condition||Treatment or Intervention||Phase|
|stage II breast cancer |
stage IIIA breast cancer
stage IIIB breast cancer
| Drug: carboplatin |
Procedure: biological response modifier therapy
Procedure: bone marrow ablation with stem cell support
Procedure: bone metastases prevention
Procedure: colony-stimulating factor therapy
Procedure: cytokine therapy
Procedure: high-dose chemotherapy
Procedure: peripheral blood stem cell transplantation
|Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Randomized Study of Doxorubicin, Cyclophosphamide, and Paclitaxel (ACT) Versus Cyclophosphamide, Thiotepa, and Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer
- Compare the toxic effects of doxorubicin, cyclophosphamide, and paclitaxel vs cyclophosphamide, thiotepa, and carboplatin in patients with high-risk primary breast cancer. (Arm I temporarily closed as of 12/12/2002.)
- 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, all 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 temporarily closed as of 12/12/2002.)
- Arm I (ACT): 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 I temporarily closed as of 12/12/2002).
- 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.
Ages Eligible for Study: up to 60 Years, Genders Eligible for Study: Both
- 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
- Not specified
- Karnofsky 80-100%
- See Disease Characteristics
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- SGOT or SGPT no greater than 2 times upper limit of normal
- Hepatitis B antigen negative
- Creatinine no greater than 1.2 mg/dL
- Creatinine clearance at least 70 mL/min
- No prior hemorrhagic cystitis
- Ejection fraction at least 55% by MUGA
- No prior significant valvular heart disease or arrhythmia
- 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
- 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
- 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
- At least 4 weeks since prior hormonal therapy
- At least 4 weeks since prior radiotherapy
- No prior radiation to the left chest wall
- Not specified
Location and Contact Information
Banner Good Samaritan Medical Center, Phoenix, Arizona, 85006, United States; Recruiting
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Record last reviewed: May 2004
Last Updated: February 24, 2005
Record first received: December 10, 1999
ClinicalTrials.gov Identifier: NCT00004092
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005