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A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer.

Phase 1
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer.



- To determine the maximum tolerable dose and assess the safety and tolerability of
imatinib mesylate in combination with capecitabine and cisplatin in patients with
unresectable or metastatic gastric cancer.


- To assess the preliminary antitumor activity of this regimen in these patients.

- To assess the response with regard to the expression and/or mutation of the tyrosine
kinase receptors PDGF-R and c-kit in gastric cancer.

OUTLINE: This is a dose-escalation study of imatinib mesylate.

Patients receive oral imatinib mesylate once daily on days -4 to 21 in course 1 and on days
1-21 in all subsequent courses, oral capecitabine twice daily on days 1-14, and cisplatin IV
on day 1. Courses repeat every 3 weeks* for 12 months in the absence of disease progression
or unacceptable toxicity.

NOTE: *First course is 25 days.

After completion of study therapy, patients are followed every 3 weeks.

Inclusion Criteria


- Histologically confirmed gastric cancer

- Unresectable and/or metastatic disease

- Incurable with any conventional multimodality approach by interdisciplinary
assessment of the local tumor board

- Immunohistochemical documentation of c-kit (CD117) and PDGF-R overexpression by tumor
if obtainable (preferably on a tumor sample taken within 6 weeks of study entry)

- At least one evaluable site of disease according to RECIST criteria

- No known brain metastasis or CNS disorder that might alter study compliance or may
worsen during or following therapy


- ECOG performance status 0-2

- WBC ≥ 3,000/μL

- ANC ≥ 2,000/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 9.0 g/dL

- Total bilirubin < 2 times upper limit of normal (ULN)

- SGOT and SGPT < 2.5 times ULN (5 times ULN if hepatic metastases present)

- Glomerular filtration rate ≥ 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for up to 3
months after completion of study treatment

- No known or documented hypersensitivity against fluoropyrimidines, tyrosine kinase
inhibitors, cisplatin, other platinums, or their respective derivatives

- No gastrointestinal disorder that might affect the gastrointestinal absorption of
capecitabine or imatinib mesylate or ability to swallow for the oral administration
of capecitabine or imatinib mesylate

- At least 5 years since prior primary malignancy except if the other primary
malignancy is not currently clinically significant nor requiring active intervention,
or if other primary malignancy is a basal cell skin cancer or carcinoma in situ of
the cervix

- No other concurrent malignant disease

- No NYHA class III-IV cardiac disease (i.e., congestive heart failure or myocardial
infarction within the past 6 months)

- No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic
renal disease, or active uncontrolled infection)

- No known neuropathy, impaired hearing, history of seizures, and/or psychiatric
disorder that might alter study compliance or may worsen during or following therapy

- No documented dihydropyrimidine dehydrogenase deficiency

- No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)

- No known diagnosis of HIV infection or other serious uncontrolled infections

- No significant history of non-compliance to medical regimens or inability to grant
reliable informed consent


- No chemotherapy or investigational agents within the past 4 weeks (6 weeks for
nitrosoureas or mitomycin C) unless the disease is rapidly progressing

- No prior radiotherapy to ≥ 25% of the bone marrow

- No major surgery within the past 2 weeks

- No concurrent warfarin or acetaminophen

- Therapeutic anticoagulation using heparin or low-molecular weight heparin

- No concurrent sorivudine or related substances

- No other concurrent anticancer agents, including chemotherapy and biologic agents

- No other concurrent investigational drugs

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Matthias Ebert, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Technische Universität München


United States: Federal Government

Study ID:




Start Date:

November 2007

Completion Date:

January 2012

Related Keywords:

  • Gastric Cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • Stomach Neoplasms