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Status:

COMPLETED

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

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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. Colon...

Detailed Description

OBJECTIVES: Primary * Determine the pathological complete response rate in patients with stage II or III breast cancer treated with neoadjuvant docetaxel, carboplatin, and pegfilgrastim. Secondary ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of breast cancer
  • Clinical stage II or III disease (including T2-4, N0-3)
  • No clinical or radiological evidence of distant metastases
  • Isolated supraclavicular lymph node involvement allowed
  • 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
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after study treatment
  • No active unresolved infection
  • No history of severe hypersensitivity reaction to docetaxel, carboplatin, or any other drug formulated with polysorbate 80
  • No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or pegfilgrastim
  • No peripheral neuropathy ≥ grade 2
  • No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • Surgery
  • No prior surgical resection for invasive breast cancer
  • Other
  • No other prior therapy for invasive breast cancer

Exclusion

    Key Trial Info

    Start Date :

    August 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    58 Patients enrolled

    Trial Details

    Trial ID

    NCT00107510

    Start Date

    August 1 2005

    Last Update

    July 6 2016

    Active Locations (120)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 30 (120 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    3

    Rush-Copley Cancer Care Center

    Aurora, Illinois, United States, 60507

    4

    St. Joseph Medical Center

    Bloomington, Illinois, United States, 61701