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High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Poor-Prognosis Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Fox Chase Cancer Center
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00002509
First received: November 1, 1999
Last updated: September 30, 2010
Last verified: September 2010
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with combinations of drugs may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation or autologous bone marrow transplantation in women with stage II breast cancer with eight or more positive axillary lymph nodes and in women with stage III or metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: mesna
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HIGH-DOSE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CARBOPLATIN FOLLOWED BY RESCUE WITH AUTOLOGOUS BONE MARROW AND AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH POOR PROGNOSIS BREAST CANCER

Resource links provided by NLM:


Further study details as provided by Temple University:

Study Start Date: November 1991
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Investigate the curative potential of high-dose cyclophosphamide, etoposide, and carboplatin followed by autologous stem cell rescue in women with breast cancer considered incurable by conventional therapy. II. Observe the overall response rate, survival rate, and toxicity associated with this regimen.

OUTLINE: Prior to therapy, patients undergo collection of peripheral blood stem cells (PBSC) on another protocol; patients with marrow involvement undergo PBSC harvest only, while all others may also undergo bone marrow harvest. All patients receive cyclophosphamide, etoposide, and carboplatin over 4 consecutive days, followed 3 days later by PBSC or bone marrow and granulocyte colony-stimulating factor. Patients are followed for duration of remission and survival.

PROJECTED ACCRUAL: 100-200 patients will be entered.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed invasive (stage II-IV) carcinoma of the breast 8 or more positive axillary nodes required for stage II disease Chemotherapy-responsive disease required of patients with measurable or evaluable disease Partial or complete response to 3 courses of standard cyclophosphamide/doxorubicin/fluorouracil (CAF) or, for patients who have had CAF, cyclophosphamide/methotrexate/fluorouracil (CMF) 3-month course of standard mitomycin/vinblastine or paclitaxel acceptable in patients clearly resistant to CAF or CMF Visceral response despite progression in bone will be considered on an individual basis Patients with no evidence of disease may be entered without evidence of a chemotherapy response Resectable disease must be surgically removed prior to transplantation Hormone receptor status: If estrogen-receptor positive, prior failure with at least 1 hormonal manipulation required unless patient is premenopausal or has rapidly progressing visceral disease No more than 20% of marrow involved with tumor

PATIENT CHARACTERISTICS: Age: 15 to 60 Sex: Women only Menopausal status: Not specified Performance status: Karnofsky 80%-100% Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL AST less than 2 times normal Albumin at least 3.0 g/dL Renal: Creatinine less than 1.8 mg/dL BUN less than 20 mg/dL Cardiovascular: Left ventricular ejection fraction at least 55% Pulmonary: DLCO, FEV1, and FVC at least 50% of predicted pO2 at least 70 mm Hg on room air Other: No serious psychiatric, neurologic, or medical illness that would compromise the safety of a bone marrow transplant Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: No prior chest irradiation other than to locally involved lymph nodes Surgery: See Disease Characteristics

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002509

Locations
United States, Pennsylvania
Temple University Cancer Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Fox Chase Cancer Center
Investigators
Study Chair: Thomas R. Klumpp, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Klumpp TR, Goldberg SL, Mangan KF, et al.: High dose cyclophosphamide, etoposide, and carboplatin (CEC) with autologous stem cell rescue for chemosensitive metastatic and high risk breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-245, 111, 1994.

Responsible Party: Temple University Bone Marrow Transplant Program, Temple University Health Systems
ClinicalTrials.gov Identifier: NCT00002509     History of Changes
Other Study ID Numbers: CDR0000078064, TUHSC-1992, NCI-V92-0205
Study First Received: November 1, 1999
Last Updated: September 30, 2010
Health Authority: United States: Federal Government

Keywords provided by Temple University:
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Cyclophosphamide
Etoposide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014