Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183833
First received: September 9, 2005
Last updated: July 24, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Colon Cancer
Colorectal Cancer
Drug: capecitabine, imatinib mesylate
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Xeloda and Gleevec in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by University of Southern California:

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the time to progression, survival and response rate. [ Time Frame: Until Patient goes off study ] [ Designated as safety issue: No ]
  • To obtain preliminary data on molecular correlates to determine clinical efficacy [ Time Frame: Until Patient Goes off study ] [ Designated as safety issue: No ]
  • Toxicity. [ Time Frame: 30 days after patient receives last drug dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 49
Study Start Date: December 2002
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Xeloda plus gleevec
Drug: capecitabine, imatinib mesylate
Capecitabine and imatinib mesylate will both be taken by mouth twice a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183833

Locations
United States, California
USC/Norris Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Novartis
Investigators
Principal Investigator: Heinz-Josef Lenz, M.D. U.S.C./Norris Cancer Center
  More Information

No publications provided

Responsible Party: Syma Iqbal, M.D., U.S.C./Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00183833     History of Changes
Other Study ID Numbers: 3C-02-1
Study First Received: September 9, 2005
Last Updated: July 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
phase 1
phase I
phase one
colon cancer
colorectal cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Imatinib
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014