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Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

Primary Purpose

Colon Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
capecitabine, imatinib mesylate
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring phase 1, phase I, phase one, colon cancer, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC/Norris Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Xeloda plus gleevec

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To determine the time to progression, survival and response rate.
To obtain preliminary data on molecular correlates to determine clinical efficacy
Toxicity.

Full Information

First Posted
September 9, 2005
Last Updated
May 20, 2014
Sponsor
University of Southern California
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00183833
Brief Title
Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors
Official Title
Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Colorectal Cancer
Keywords
phase 1, phase I, phase one, colon cancer, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Xeloda plus gleevec
Intervention Type
Drug
Intervention Name(s)
capecitabine, imatinib mesylate
Intervention Description
Capecitabine and imatinib mesylate will both be taken by mouth twice a day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine the time to progression, survival and response rate.
Time Frame
Until Patient goes off study
Title
To obtain preliminary data on molecular correlates to determine clinical efficacy
Time Frame
Until Patient Goes off study
Title
Toxicity.
Time Frame
30 days after patient receives last drug dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz-Josef Lenz, M.D.
Organizational Affiliation
U.S.C./Norris Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

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