Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV
NCT00041340CI-TRIAL-00009064completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate)
- 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.
- interventionNames
- Drug: imatinib mesylate
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.