Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colon Cancer
• Intervention / Treatment: Drug: capecitabine, imatinib mesylate

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC/Norris Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Novartis
• Investigators: Principal Investigator: Heinz-Josef Lenz, M.D., U.S.C./Norris Cancer Center

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: colorectal cancer; phase 1; colon cancer; phase I; phase one
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Capecitabine; Imatinib Mesylate
• Other Study ID Numbers: 3C-02-1