DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: capecitabine (Drug); paclitaxel albumin-stabilized nanoparticle formulation (Drug); neoadjuvant therapy (Procedure)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Washington Hospital Center

Official(s) and/or principal investigator(s):
Anita Aggarwal, DO, PhD, Study Chair, Affiliation: Washington Hospital Center

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III breast cancer.

Clinical Details

Official title: Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pathological complete response rate

Secondary outcome:

Safety

Overall clinical response rate

Detailed description: OBJECTIVES: Primary

- Determine the rate of pathological complete response (i. e., tumor completely gone) in

women with previously untreated, unresected, stage II-IIIB breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized nanoparticle formulation) (Abraxane^®). Secondary

- Evaluate the safety of this regimen in these patients.

- Determine overall clinical response rate in patients treated with this regimen.

OUTLINE: Patients receive up to 4 courses of capecitabine and paclitaxel (nanoparticle albumin-stabilized formulation) (Abraxane^®) in the absence of disease progression. Patients then undergo definitive surgical resection of the tumor off study. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast

cancer

- Stage II-IIIB disease (T1-4, N1-2, M0)

- Previously untreated disease

- Previously unresected disease

- High-risk disease that is not resectable by lumpectomy alone

- Any HER2/neu status (positive, negative, or unknown) allowed

- Hormone receptor status:

- Any estrogen/progesterone status (positive, negative, or unknown) allowed

PATIENT CHARACTERISTICS:

- Female

- Menopausal status not specified

- ECOG performance status 0-2

- Life expectancy > 3 months

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Hemoglobin > 9. 0 g/dL

- Creatinine < 1. 5 mg/dL

- Bilirubin < 1. 5 times upper limit of normal (ULN)

- ALT and AST < 2. 5 times ULN (5 times ULN if due to Gilbert's disease)

- Alkaline phosphatase < 2. 5 times ULN (5 times ULN if due to Gilbert's disease)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Locations and Contacts

Washington Cancer Institute at Washington Hospital Center, Washington, District of Columbia 20010, United States; Recruiting
Clinical Trials Office - Washington Cancer Institute, Phone: 202-877-8839
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2006
Last updated: February 6, 2009

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017