Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer
Recruitment status was Active, not recruiting
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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 Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | October 2002 |
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 |
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| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| Principal Investigator: | Lisle M. Nabell, MD | University of Alabama at Birmingham |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00096343 History of Changes |
| Other Study ID Numbers: | CDR0000377728, UAB-0137 |
| Study First Received: | November 9, 2004 |
| Last Updated: | May 30, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 Carboplatin Paclitaxel Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013