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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. Identifier: NCT00183833
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Colorectal Cancer Drug: capecitabine, imatinib mesylate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors
Study Start Date : December 2002
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Xeloda plus gleevec
Drug: capecitabine, imatinib mesylate
Capecitabine and imatinib mesylate will both be taken by mouth twice a day

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine the time to progression, survival and response rate. [ Time Frame: Until Patient goes off study ]
  2. To obtain preliminary data on molecular correlates to determine clinical efficacy [ Time Frame: Until Patient Goes off study ]
  3. Toxicity. [ Time Frame: 30 days after patient receives last drug dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00183833

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United States, California
USC/Norris Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
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Principal Investigator: Heinz-Josef Lenz, M.D. U.S.C./Norris Cancer Center
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Responsible Party: University of Southern California Identifier: NCT00183833    
Other Study ID Numbers: 3C-02-1
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014
Keywords provided by University of Southern California:
phase 1
phase I
phase one
colon cancer
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Imatinib Mesylate
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors