ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006108
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: paclitaxel
Drug: trastuzumab
Phase I
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Paclitaxel    Capecitabine    Trastuzumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Xeloda, Every Three Week Taxol and Herceptin in Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 1999

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with paclitaxel and trastuzumab (Herceptin) in patients with metastatic breast cancer. II. Determine the response rate of these patients to this treatment regimen. III. Determine the median time to treatment failure in these patients with this treatment regimen. IV. Determine the incidence of cardiac toxicity in these patients with this treatment regimen. V. Assess the quality of life in these patients.

OUTLINE: This is a dose escalation study of capecitabine. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours on day 2; and oral capecitabine on days 3-16. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued. Quality of life is assessed at baseline and after 3 courses of treatment.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I dose escalation portion of this study. A total of 28-41 patients will be accrued for the phase II portion of this study.

  Eligibility
Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic disease HER2 overexpressing tumor (2+ or 3+) Bidimensionally measurable or evaluable disease Hormone receptor status: Estrogen receptor positive or negative

PATIENT CHARACTERISTICS: Age: 18 to 59 Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Ejection fraction at least 50% by MUGA No history of congestive heart failure No uncontrolled cardiac arrhythmias Other: No other prior malignancy except squamous cell or basal cell carcinoma of the skin, noninvasive ductal carcinoma of the breast, or cervical dysplasia No prior motor or sensory neuropathy grade 2 or higher Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior trastuzumab (Herceptin) No concurrent hematopoietic growth factors Chemotherapy: No prior chemotherapy for metastatic disease Prior adjuvant chemotherapy allowed (including regimens containing doxorubicin) No prior paclitaxel, 24 hour infusion fluorouracil, or capecitabine Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 50% or more of the bone marrow Surgery: Not specified Other: No other concurrent experimental drugs

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006108

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC    
      Chapel Hill, North Carolina, United States, 27599-7295

Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Frances A. Collichio, MD     UNC Lineberger Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068119, UNC-9904, NCI-G00-1834
First Received:   August 3, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006108
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer  
recurrent breast cancer  

Study placed in the following topic categories:
Capecitabine
Skin Diseases
Paclitaxel
Trastuzumab
Breast Neoplasms
Breast Diseases
Recurrence

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

ClinicalTrials.gov processed this record on October 03, 2008




Links to all studies - primarily for crawlers