Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00096343
First received: November 9, 2004
Last updated: December 2, 2013
Last verified: November 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating women who are undergoing surgery for newly diagnosed, locally advanced breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: carboplatin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin [ Time Frame: baseline to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen [ Time Frame: baseline through 18 months ] [ Designated as safety issue: No ]
  • Determine the tolerability and toxicity of this regimen in these patients. [ Time Frame: baseline to 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: October 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel IV followed by Carboplatin IV
paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: carboplatin Drug: paclitaxel

Detailed Description:

OBJECTIVES:

  • Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin.
  • Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen.
  • Determine the tolerability and toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks before beginning neoadjuvant chemotherapy.

All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo lumpectomy or modified radical mastectomy. Patients with a positive sentinel lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection. All patients undergoing lumpectomy or mastectomy with high-risk disease also undergo radiotherapy.

Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core needle biopsy.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast meeting the following stage criteria:

    • T2, T3, or T4a-c
    • N0-2
    • M0
  • Inflammatory breast cancer (stage IIIB) allowed
  • Measurable disease by mammogram or ultrasound
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.2 times ULN OR
  • Creatinine clearance ≥ 50 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No comorbid medical condition that would preclude study participation
  • No comorbid infection that would preclude study participation
  • No clinically significant peripheral neuropathy (> grade 1)
  • No prior significant allergic reaction to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K
  • No dementia or altered mental status that would prohibit understanding of informed consent
  • No other primary malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic growth factors

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • At least 3 weeks since prior surgery

Other

  • No other concurrent anticancer drugs
  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: NCT00096343

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Lisle M. Nabell, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00096343     History of Changes
Other Study ID Numbers: CDR0000377728, UAB-0137
Study First Received: November 9, 2004
Last Updated: December 2, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
invasive ductal breast carcinoma
invasive lobular breast carcinoma
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
inflammatory breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014