Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00183833
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE December 2002
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Gleevec in combination with a fixed dose of Xeloda po bid daily in patients with colon cancer. [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Gleevec in combination of Xeloda at 650mg/m2 po bid daily in patients with colon cancer.
Change History Complete list of historical versions of study NCT00183833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
  • To determine the time to progression, survival and response rate. [ Time Frame: Until Patient goes off study ]
  • To obtain preliminary data on molecular correlates to determine clinical efficacy [ Time Frame: Until Patient Goes off study ]
  • Toxicity. [ Time Frame: 30 days after patient receives last drug dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • To determine the pharmacokinetic and pharmacodynamic data of Gleevec when given in combination with Xeloda.
  • To determine the time to progression, survival and response rate in patients with Colon Cancer who failed 5-FU/LV and CPT-11 based chemotherapy.
  • To obtain preliminary data on molecular correlates to determine clinical efficacy
  • and toxicity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors
Official Title  ICMJE Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors
Brief Summary

This study is for people with solid tumors cancer for which the standard chemotherapy drugs have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also called capecitabine) in combination with a new anticancer agent called Gleevec (also called imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a leukemia called CML (increase of white blood cells) after failure of standard therapy. It is also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in the digestive tract).

This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colon Cancer
  • Colorectal Cancer
Intervention  ICMJE Drug: capecitabine, imatinib mesylate
Capecitabine and imatinib mesylate will both be taken by mouth twice a day
Study Arms  ICMJE Experimental: A
Xeloda plus gleevec
Intervention: Drug: capecitabine, imatinib mesylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2014)
40
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
49
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
  • SWOG performance status 0-2.
  • ANC greater than 1500, platelets greater than 100,000.
  • Total bilirubin less than 2 x upper limit of normal, or less than 3 x upper limit of normal in patients with liver metastasis. Transaminase (AST and/or ALT) less than 2 x upper limit of normal or less than 3 x upper limit of normal in patients with liver metastasis.
  • Serum creatinine less than 1.25 x institutional upper limit of normal.
  • Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.

Exclusion Criteria:

  • Patient has received any other investigational agent- within 28 days of first day of study drug dosing.
  • Patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
  • Patient has another severe and/or life-threatening medical disease.
  • Patient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
  • Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by Novartis.
  • Patient had a major surgery within 2 weeks prior to study entry.
  • Patients with symptomatic brain metastasis.
  • Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study)
  • Medical, social or psychological factors interfering with compliance.
  • Patients under therapeutic coumadin therapy.
  • Patients under routine systemic corticosteroid therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00183833
Other Study ID Numbers  ICMJE 3C-02-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Heinz-Josef Lenz, M.D. U.S.C./Norris Cancer Center
PRS Account University of Southern California
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP