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Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

Primary Purpose

Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Colon Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (imatinib mesylate)

Arm Description

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.

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Full Information

First Posted
July 8, 2002
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00041340
Brief Title
Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
Official Title
Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer. Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth
Detailed Description
PRIMARY OBJECTIVES: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (imatinib mesylate)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
CGP 57148, Gleevec, Glivec
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Razelle Kurzrock
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

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