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Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
This study has been completed.
Study NCT00041340   Information provided by National Cancer Institute (NCI)
First Received: July 8, 2002   Last Updated: July 23, 2008   History of Changes

July 8, 2002
July 23, 2008
May 2002
 
Response by RECIST criteria at 8 weeks [ Designated as safety issue: No ]
Response by RECIST criteria at 8 weeks
Complete list of historical versions of study NCT00041340 on ClinicalTrials.gov Archive Site
Biologic effects by patient reports and observations at 8 weeks or completion of study treatment [ Designated as safety issue: No ]
Biologic effects by patient reports and observations at 8 weeks or completion of study treatment
 
Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer.

OBJECTIVES:

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

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.

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

Phase II
Interventional
Treatment, Open Label
Colorectal Cancer
Drug: imatinib mesylate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
37
 
 

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

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

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

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00041340
 
CDR0000069475, MDA-ID-01557, NCI-5652
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Razelle Kurzrock, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP