Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

Recurrent Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041340
• Other study ID #: NCI-2012-02479
• Secondary ID: ID01-557N01CM622
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2002
• Last updated: January 22, 2013
• Start date: May 2002

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• imatinib mesylate
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Up to 4 years	No