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Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
This study has been completed.
First Received: July 8, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041340
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response by RECIST criteria at 8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biologic effects by patient reports and observations at 8 weeks or completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: May 2002
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041340

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Razelle Kurzrock, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069475, MDA-ID-01557, NCI-5652
Study First Received: July 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00041340     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases
Protein Kinase Inhibitors
Pharmacologic Actions
Intestinal Neoplasms
Imatinib
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009