Clinical Trial: Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

This study is not yet open for patient recruitment.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and carboplatin together with pegfilgrastim before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer.

Condition Treatment or Intervention Phase
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Male Breast Cancer
 Drug: carboplatin
 Drug: docetaxel
 Drug: pegfilgrastim
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: conventional surgery
 Procedure: cytokine therapy
 Procedure: neoadjuvant therapy
 Procedure: surgery
Phase II

MedlinePlus related topics:  Breast Cancer;   Male Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Neoadjuvant Docetaxel, Carboplatin, and Pegfilgrastim in Patients With Stage II or III Breast Cancer

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Determine the toxicity profile of this regimen in these patients.
  • Determine the rate of breast-conserving surgery in patients treated with this regimen.
  • Determine the clinical response rate in patients treated with this regimen.
  • Determine the feasibility of drug administration, in terms of the percent of planned dose actually administered per course, in patients treated with this regimen.
  • Determine the proportion of patients with negative pathologic lymph node status after treatment with this regimen.
  • Determine the proportion of patients with residual ductal carcinoma in situ after treatment with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.

After completion of study therapy, patients are followed every 6 months until disease progression and then annually for up to 5 years. Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 25-58 patients will be accrued for this study within 21-23 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL

Hepatic

  • Bilirubin normal
  • Meets 1 of the following criteria:
  • AST or ALT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal
  • AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
  • AST or ALT normal AND alkaline phosphatase ≤ 5 times ULN

Renal

  • Creatinine clearance ≥ 30 mL/min

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

Other


Location Information

Study chairs or principal investigators

Vivek Roy, MD, MRCP,  Study Chair,  Mayo Clinic - Jacksonville   
Edith A. Perez, MD,  Mayo Clinic - Jacksonville   
Barbara A. Pockaj, MD,  CCOP - Mayo Clinic Scottsdale Oncology Program   
Robert Chambers, MD,  MeritCare Clinic - Wahpeton   
Judith E. Hurley, MD,  Sylvester Cancer Center   

More Information

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

Study ID Numbers:  CDR0000420834; NCCTG-N0338
Record last reviewed:  March 2005
Last Updated:  April 5, 2005
Record first received:  April 5, 2005
ClinicalTrials.gov Identifier:  NCT00107510
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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