Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
Completed · Phase 2
Conditions studied: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer
In brief
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
Key facts
- Study ID
- NCT00041340
- Run by
- National Cancer Institute (NCI)
- People needed
- 37
- Starts
- 2002-05-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.