A Phase II Multi-Institution Study of Docetaxel and Doxorubicin as Induction Therapy Followed by Sequential High Dose Chemotherapy and CD 34+ Selected Stem Cell Support for Women With Metastatic Breast Cancer
18 Years
65 Years
Female
Breast Cancer
Trial Information
A Phase II Multi-Institution Study of Docetaxel and Doxorubicin as Induction Therapy Followed by Sequential High Dose Chemotherapy and CD 34+ Selected Stem Cell Support for Women With Metastatic Breast Cancer
OBJECTIVES: I. Assess the toxicity and response rates to induction therapy with docetaxel
and doxorubicin in women with chemotherapy naive metastatic breast cancer. II. Assess the
toxicity and response rates to sequential high dose chemotherapy following induction
chemotherapy in women with metastatic breast cancer. III. Determine the hematopoietic
recovery rate following CD34+ selected peripheral blood stem cell support in this patient
population. IV. Assess the toxicity of noncytotoxic maintenance therapy following high dose
chemotherapy in this patient population.
OUTLINE: This is a multicenter study. Patients with no prior chemotherapy for metastatic
disease receive induction chemotherapy consisting of doxorubicin IV immediately followed by
docetaxel IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) subcutaneously (SQ)
beginning on day 2 and continuing until day 11-15. Induction therapy repeats every 3 weeks
for 4 courses. Within 4 weeks of the last course of induction chemotherapy, patients receive
mobilization chemotherapy consisting of cyclophosphamide IV for 2 days, and etoposide IV and
cisplatin IV for 3 days. At 24 hours following completion of chemotherapy, patients receive
G-CSF SQ twice daily until the target number of peripheral blood stem cells (PBSC) are
reached. Within 5 weeks following completion of mobilization chemotherapy, patients receive
cyclophosphamide IV, thiotepa IV, and carboplatin IV continuously on days -7 through -4.
Patients receive CD34+ selected PBSC on day 0 followed 4 hours later by G-CSF SQ daily and
continuing until blood counts recover. Within 30 days of blood count recovery or immediately
following completion of post transplantation radiotherapy, patients receive maintenance
therapy consisting of oral anastrozole daily until disease progression. Patients with bone
involvement also receive pamidronate IV over 2 hours monthly for 1 year. Patients are
followed monthly for 6 months, every 3 months for 1 year, every 4-6 months for 5 years, and
then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of the breast
Metastatic disease including ipsilateral supraclavicular lymph nodes and the chest wall
(no axillary nodes) Measurable or evaluable (bone only) disease on exam or radiography No
apocrine, adenocystic, squamous cell carcinoma, sarcoma, or lymphoma No symptomatic CNS
disease or clinical evidence of CNS metastases Surgically accessible disease Hormone
receptor status: Progesterone or estrogen receptor status known
PATIENT CHARACTERISTICS: Age: 18 to 65 Menopausal status: Not specified Performance
status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3
Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 3.0 mg/dL SGOT no
greater than 6 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance greater than 50 mL/min Cardiovascular: Ejection fraction at least 40%
by MUGA scan No angina pectoris requiring active nitrate therapy No myocardial infarction
within the past 6 months No uncontrolled congestive heart failure No uncontrolled
hypertension No major ventricular arrhythmia Other: No uncompensated endocrine dysfunction
HIV negative Hepatitis B negative (core antigen negative if vaccinated) No other prior
malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or
carcinoma in situ of the cervix No active infection or other medical condition that would
preclude study Not pregnant Negative pregnancy test Fertile patients must use effective
contraception
PRIOR CONCURRENT THERAPY: At least 6 months since prior adjuvant therapy Biologic therapy:
Not specified Chemotherapy: No more than 2 courses of prior induction docetaxel and
doxorubicin allowed if staged within 4 weeks of chemotherapy initiation No prior
cumulative adjuvant doxorubicin dose greater than 360 mg/m2 No other prior chemotherapy
for metastatic disease Endocrine therapy: Prior hormonal therapy for metastatic disease
allowed Radiotherapy: Not specified Surgery: See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Andrew L. Pecora, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Hackensack University Medical Center Cancer Center
Authority:
United States: Federal Government
Study ID:
NU-H97B1
NCT ID:
NCT00004906
Start Date:
October 1999
Completion Date:
June 2001
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
