|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004906 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: filgrastim Drug: anastrozole Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: etoposide Drug: pamidronate disodium Drug: thiotepa Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | 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 |
| Study Start Date: | October 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Pennsylvania | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Chair: | Andrew L. Pecora, MD, FACP | Hackensack University Medical Center Cancer Center |
More Information
| Study ID Numbers: | CDR0000067586, NU-H97B1, NCI-G00-1682 |
| Study First Received: | March 7, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004906 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Anastrozole Antineoplastic Agents, Hormonal Immunologic Factors Skin Diseases Breast Neoplasms Bone Density Conservation Agents Cyclophosphamide Carboplatin Immunosuppressive Agents Etoposide phosphate Recurrence Doxorubicin |
Thiotepa Docetaxel Anti-Bacterial Agents Cisplatin Pamidronate Antineoplastic Agents, Alkylating Aromatase Inhibitors Antirheumatic Agents Alkylating Agents Etoposide Breast Diseases |
|
Anastrozole Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bone Density Conservation Agents Cyclophosphamide Antibiotics, Antineoplastic Docetaxel Neoplasms by Site Therapeutic Uses Pamidronate Aromatase Inhibitors Alkylating Agents |
Breast Diseases Skin Diseases Antineoplastic Agents, Hormonal Breast Neoplasms Enzyme Inhibitors Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |
