Expired Study
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Birmingham, Alabama 35294


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000377728


NCT ID:

NCT00096343


Secondary ID:

UAB-0137


Study Acronym:


Brief Title:

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


Official Title:

A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Alabama at Birmingham


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

31


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lisle M. Nabell, MD
Principal Investigator
University of Alabama at Birmingham

Study Dates

Start Date:October 2002
Completion Date:March 2005
Completion Type:Actual
Primary Completion Date:March 2005
Primary Completion Type:Actual
Verification Date:November 2018
Last Changed Date:November 30, 2018
First Received Date:November 9, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Determine the tolerability and toxicity of this regimen in these patients.
Time Frame:baseline to 18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen
Time Frame:baseline through 18 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:carboplatin
Arm Name:Paclitaxel IV followed by Carboplatin IV
Intervention Type:Drug
Name:paclitaxel
Arm Name:Paclitaxel IV followed by Carboplatin IV

Study Arms

Study Arm Type:Experimental
Arm Name:Paclitaxel IV followed by Carboplatin IV
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Alabama at Birmingham
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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