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

Phase 1
18 Years
Not Enrolling
Colon Cancer, Colorectal Cancer

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Trial Information

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

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

- 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

- 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,

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Heinz-Josef Lenz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.S.C./Norris Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

Related Keywords:

  • Colon Cancer
  • Colorectal Cancer
  • phase 1
  • phase I
  • phase one
  • colon cancer
  • colorectal cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms



USC/Norris Cancer Center Los Angeles, California