Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV
N/A
N/A
Both
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer
Trial Information
Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
Up to 4 years
Safety Issue:
No
Principal Investigator
Razelle Kurzrock
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02479
NCT ID:
NCT00041340
Start Date:
May 2002
Completion Date:
Related Keywords:
- Recurrent Colon Cancer
- Recurrent Rectal Cancer
- Stage IV Colon Cancer
- Stage IV Rectal Cancer
- Colonic Neoplasms
- Rectal Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| M D Anderson Cancer Center | Houston, Texas 77030 |
