Clinical trial · Interventional
Imatinib, Capecitabine, and Cisplatin in Treating Patients With Unresectable or Metastatic Stomach Cancer
A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer.
- 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 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib when given together with capecitabine and cisplatin in treating patients with unresectable or metastatic stomach cancer.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib mesylate
- description
- Imatinib mesylate 300mg/day(maximum dose will be 800 mg) on day -4, -3, -2, -1, 1, 2, 3 through d21 in combination with capecitabine 1250 mg/m2 twice daily (d1-d14) and iv cisplatin 60mg/m2
- interventionNames
- Drug: capecitabine
- Drug: cisplatin
- Drug: imatinib mesylate
Primary outcomes (3)
- measure
- Safety
- measure
- Tolerability
- measure
- Overall tumor response as assessed by RECIST
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed gastric cancer * Unresectable and/or metastatic disease * Incurable with any conventional multimodality approach by interdisciplinary assessment of the local tumor board * Immunohistochemical documentation of c-kit (CD117) and PDGF-R overexpression by tumor if obtainable (preferably on a tumor sample taken within 6 weeks of study entry) * At least one evaluable site of disease according to RECIST criteria * No known brain metastasis or CNS disorder that might alter study compliance or may worsen during or following therapy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC ≥ 3,000/μL * ANC ≥ 2,000/μL * Platelet count ≥ 100,000/μL * Hemoglobin ≥ 9.0 g/dL * Total bilirubin \< 2 times upper limit of normal (ULN) * SGOT and SGPT \< 2.5 times ULN (5 times ULN if hepatic metastases present) * Glomerular filtration rate ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for up to 3 months after completion of study treatment * No known or documented hypersensitivity against fluoropyrimidines, tyrosine kinase inhibitors, cisplatin, other platinums, or their respective derivatives * No gastrointestinal disorder that might affect the gastrointestinal absorption of capecitabine or imatinib mesylate or ability to swallow for the oral administration of capecitabine or imatinib mesylate * At least 5 years since prior primary malignancy except if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or carcinoma in situ of the cervix * No other concurrent malignant disease * No NYHA class III-IV cardiac disease (i.e., congestive heart failure or myocardial infarction within the past 6 months) * No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) * No known neuropathy, impaired hearing, history of seizures, and/or psychiatric disorder that might alter study compliance or may worsen during or following therapy * No documented dihydropyrimidine dehydrogenase deficiency * No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis) * No known diagnosis of HIV infection or other serious uncontrolled infections * No significant history of non-compliance to medical regimens or inability to grant reliable informed consent PRIOR CONCURRENT THERAPY: * No chemotherapy or investigational agents within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) unless the disease is rapidly progressing * No prior radiotherapy to ≥ 25% of the bone marrow * No major surgery within the past 2 weeks * No concurrent warfarin or acetaminophen * Therapeutic anticoagulation using heparin or low-molecular weight heparin allowed * No concurrent sorivudine or related substances * No other concurrent anticancer agents, including chemotherapy and biologic agents * No other concurrent investigational drugs
References
Publications (1)
- DERIVEDMayr M, Becker K, Schulte N, Belle S, Hofheinz R, Krause A, Schmid RM, Rocken C, Ebert MP. Phase I study of imatinib, cisplatin and 5-fluoruracil or capecitabine in advanced esophageal and gastric adenocarcinoma. BMC Cancer. 2012 Dec 10;12:587. doi: 10.1186/1471-2407-12-587. PMID 23228190