Clinical Trial: Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

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
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: filgrastim
 Drug: fluorouracil
 Drug: paclitaxel
 Drug: pamidronate
 Drug: thiotepa
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone metastases prevention
 Procedure: chemotherapy
 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

Further Study Details: 

OBJECTIVES:

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.)

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.

Eligibility

Ages Eligible for Study:  up to  60 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • Physiological age 60 or under

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • See Disease Characteristics

Hematopoietic:

  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT or SGPT no greater than 2 times upper limit of normal
  • Hepatitis B antigen negative

Renal:

  • Creatinine no greater than 1.2 mg/dL
  • Creatinine clearance at least 70 mL/min
  • No prior hemorrhagic cystitis

Cardiovascular:

  • Ejection fraction at least 55% by MUGA
  • No prior significant valvular heart disease or arrhythmia

Pulmonary:

  • 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

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiation to the left chest wall

Surgery:

  • Not specified

Location and Contact Information


Arizona
      Banner Good Samaritan Medical Center, Phoenix,  Arizona,  85006,  United States; Recruiting
Jeffrey Schriber, MD  602-239-4526    jeffrey.schriber@bannerhealth.com 

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
Clinical Trials Office - New Patient Services  800-826-4673    becomingapatient@coh.org 

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067305; CHNMC-IRB-98096; CHNMC-PHII-18; NCI-H99-0038; NCT00004092
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005