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

NCT00096343 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000377728UAB-0137
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

invasive ductal breast carcinoma; invasive lobular breast carcinoma; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; inflammatory breast cancer

Outcome Measures

Primary Outcomes (1)

• Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin

  baseline to 18 months

Secondary Outcomes (2)

• Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen

  baseline through 18 months

• Determine the tolerability and toxicity of this regimen in these patients.

  baseline to 18 months

Study Arms (1)

Paclitaxel IV followed by Carboplatin IV

EXPERIMENTAL

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

Interventions

carboplatin DRUG

Paclitaxel IV followed by Carboplatin IV

paclitaxel DRUG

Paclitaxel IV followed by Carboplatin IV

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Lobular; Inflammatory Breast Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Lisle M. Nabell, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: October 1, 2002
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

US (1)