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Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV

Phase 2
Not Enrolling
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

Thank you

Trial Information

Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV


I. To determine response to Gleevec (Imatinib Mesylate) in patients with metastatic
colorectal cancer and with c-Kit, Arg, Abl, or PDGF-R expression.

II. To determine the side effects of Imatinib Mesylate in patients with colorectal cancer.

III. To study the biologic effects of Imatinib Mesylate on the c-Kit and PDGF-R system and
downstream signaling in metastatic colorectal cancer.


Patients receive oral imatinib mesylate twice daily. Treatment continues for 8 weeks in the
absence of disease progression or unacceptable toxicity. Patients with stable disease or
better continue therapy until disease progression or 1 year after complete response.

Inclusion Criteria:

- Histologically confirmed stage IV colorectal cancer

- Arg, KIT (CD117), or PDGF-R expression (1+ in 20% of cells) in the tumor or

- At least one unidimensionally measurable lesion

- At least 10 mm by spiral CT scan

- No known brain metastases

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- At least 12 weeks

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 2.0 mg/dL

- AST/ALT less than 2.5 times upper limit of normal

- Creatinine no greater than 2.0 mg/mL

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 3 months
after study participation

- No other malignancy within the past 3 years except non-melanoma skin cancer or
carcinoma in situ of the cervix

- No concurrent uncontrolled illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

- More than 4 weeks since prior radiotherapy and recovered

- More than 3 weeks since prior surgery (excluding diagnostic biopsy)

- No other concurrent investigational agents

- No concurrent therapeutic doses of anticoagulants (e.g., warfarin)

- No concurrent grapefruit

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

Up to 4 years

Safety Issue:


Principal Investigator

Razelle Kurzrock

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms



M D Anderson Cancer Center Houston, Texas  77030