Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed Any age NCI MDA-ID-01557 NCI-5652, NCT00041340, 5652

Objectives

1. Determine the response in patients with stage IV colorectal cancer expressing c-Kit, Arg, Abl, or PDGF-R treated with imatinib mesylate.
2. Determine the side effects of this drug in these patients.
3. Determine the biologic effects of this drug on c-Kit and PDGF-R expression and downstream signaling in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IV colorectal cancer



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



• At least one unidimensionally measurable lesion
  • At least 10 mm by spiral CT scan



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

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

Endocrine therapy:

• Not specified

Radiotherapy:

• More than 4 weeks since prior radiotherapy and recovered

Surgery:

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

Other:

• 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

Patient Characteristics:

Age:

• Any age

Performance status:

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 2.0 mg/dL
• AST/ALT less than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/mL

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other:

• 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

Expected Enrollment

A total of 14-37 patients will be accrued for this study within 5-37 months.

Outcomes

Response by RECIST criteria at 8 weeks

Biologic effects by patient reports and observations at 8 weeks or completion of study treatment

Outline

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Razelle Kurzrock, MD, Protocol chair		Ph: 713-794-1226; 800-392-1611

Registry Information
Official Title		Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV
Trial Start Date		2002-05-29
Registered in ClinicalTrials.gov		NCT00041340
Date Submitted to PDQ		2002-06-03
Information Last Verified		2006-05-02
NCI Grant/Contract Number		CM17003, CA16672

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