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Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00012311
First received: March 3, 2001
Last updated: January 3, 2014
Last verified: September 2001
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if chemotherapy followed by peripheral stem cell transplantation is more effective than chemotherapy alone in treating metastatic breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation with that of chemotherapy alone in treating women who have stage IV breast cancer.


Condition Intervention Phase
Breast Cancer Biological: filgrastim Drug: CMF regimen Drug: carboplatin Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: etoposide Drug: fluorouracil Drug: ifosfamide Drug: methotrexate Drug: thiotepa Procedure: peripheral blood stem cell transplantation Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Multi-Cycle High-Dose Chemotherapy Versus Optimized Conventionally-Dosed Chemotherapy in Patients With Metastatic Breast Cancer: A Phase II Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2000
Detailed Description:

OBJECTIVES: I. Compare the efficacy of multi-course high-dose chemotherapy with autologous peripheral blood stem cell transplantation versus standard-dose chemotherapy in women with metastatic breast cancer. II. Compare the five year event-free survival, in terms of time to progression or time to death due to toxic effects, in patients treated with these regimens. III. Compare the response rate and overall survival of patients treated with these regimens. IV. Compare the toxicity of these regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel and doxorubicin once followed by filgrastim (G-CSF) daily for approximately 1 week. Treatment repeats approximately every 3 weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate, and fluorouracil on days 7 and 8 every 4 weeks for 4 courses. Arm II: Patients receive docetaxel, doxorubicin, and G-CSF as in arm I for 3 courses. Patients undergo leukapheresis daily for 3 or 4 days. Patients then receive 1 course of ifosfamide, etoposide, and carboplatin daily for 4 days when blood counts recover, followed by 1 course of cyclophosphamide and thiotepa daily for 4 days. Patients undergo peripheral blood stem cell reinfusion following each course.

PROJECTED ACCRUAL: A total of 264 patients (132 per arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IV breast carcinoma Bone metastasis as only form of metastatic disease allowed No evidence of bone marrow involvement by aspirate or biopsy No brain metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 59 Sex: Female Menopausal status: Not specified Performance status: Karnofsky 80-100% Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL PT normal Activated PTT normal Hepatic: Bilirubin normal (unless benign congenital hyperbilirubinemia is present) No AST/ALT greater than 1.5 times upper limit of normal (ULN) together with alkaline phosphatase greater than 2.5 times ULN No active hepatitis B or C Renal: Creatinine normal Cardiovascular: Ejection fraction normal by MUGA or echocardiogram No active heart disease No prior myocardial infarction or other manifestation of coronary artery disease Other: More than 1,000 calories/day oral intake HIV negative No active serious medical or psychiatric disease No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No allergy to polysorbate 80 or E. coli-derived products No peripheral neuropathy greater than grade 2 Not pregnant Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease No prior mitomycin, nitrosoureas, or platinum coordination complexes Prior adjuvant chemotherapy allowed if completed more than 6 months prior to relapse with metastases No more than 300 mg/m2 prior doxorubicin or 450 mg/m2 prior epirubicin Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the brain or marrow-bearing pelvis Prior radiotherapy to lower pelvis allowed if the upper border of the radiotherapy field is below the upper border of the acetabulum No other prior radiotherapy to the pelvis Surgery: At least 2 weeks since prior major surgery Other: No other concurrent anti-cancer therapy

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00012311

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Linda T. Vahdat, MD Herbert Irving Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00012311     History of Changes
Other Study ID Numbers: CDR0000068504
CPMC-IRB-9244
NCI-G01-1922
Study First Received: March 3, 2001
Last Updated: January 3, 2014

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Methotrexate
Fluorouracil
Doxorubicin
Etoposide
Cyclophosphamide
Thiotepa
Liposomal doxorubicin
Carboplatin
Ifosfamide
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on June 23, 2017