Clinical trial · Interventional
Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors
A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies
- 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)
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with capecitabine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with capecitabine in treating patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant solid tumors for which no standard effective therapy exists OR such therapy is refused * Previously treated brain metastases that are currently asymptomatic allowed PATIENT CHARACTERISTICS: Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 2,000/mm\^3 * Platelet count \> 100,000 mm\^3 * Hemoglobin \> 9.0 g/dL Hepatic * Alkaline phosphatase \< 2.5 times upper limit of normal (ULN) * SGOT and SGPT \< 2.5 times ULN * Bilirubin \< 1.5 times ULN Renal * Creatinine clearance \> 50 mL/min Cardiovascular * No congestive heart failure * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmias * No myocardial infarction within the past 12 months * No other clinically significant cardiac disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No prior unanticipated severe reaction to fluoropyrimidine therapy * No known sensitivity to fluorouracil PRIOR CONCURRENT THERAPY: Biologic therapy * More than 28 days since prior biologic therapy Chemotherapy * More than 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin C) Endocrine therapy * At least 90 days since prior steroids for the treatment of brain metastases * More than 28 days since prior hormonal therapy Radiotherapy * At least 90 days since prior radiotherapy for the treatment of brain metastases * More than 28 days since other prior radiotherapy * No prior pelvic radiotherapy \> 30% of the bone marrow Surgery * More than 28 days since prior surgery and recovered
References
Publications (1)
- RESULTDugan E, Truax R, Meadows KL, Nixon AB, Petros WP, Favaro J, Fernando NH, Morse MA, Blobe GC, Hurwitz HI. A phase I dose-escalation study of imatinib mesylate (Gleevec/STI571) plus capecitabine (Xeloda) in advanced solid tumors. Anticancer Res. 2010 Apr;30(4):1251-6. PMID 20530436