Clinical trial · Interventional
Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies
A Phase I Trial of Capecitabine or Continuous Infusion 5-Fluorouracil in Combination With Weekly Irinotecan and Cisplatin in Patients With Advanced Solid Tumor Malignancies
NCT00215501CI-TRIAL-00035609completedPhase 1ClinicalTrials.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)
The purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, 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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil (5-FU) | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Oral capecitabine
- interventionNames
- Drug: Capecitabine
- Drug: Irinotecan
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Group B
- description
- 5-fluorouracil
- interventionNames
- Drug: 5-Fluorouracil (5-FU)
- Drug: Irinotecan
- Drug: Cisplatin
Primary outcomes (1)
- measure
- To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed solid tumor malignancy * 18 years of age or older * Two prior chemotherapy regimens for metastatic disease. Prior chemotherapy must have been completed at least 3 weeks prior to initiation of this protocol. * ECOG performance status of 0,1 or 2 * Neutrophils greater or equal to 1,500/ul * Platelets greater or equal to 100,000/ul * Serum bilirubin less or equal to 1.5 mg/dl * Creatinine clearance greater than 50 ml/min * AST or SGOT less or equl to 3x ULN * Prior radiotherapy is allowable, provided at least 4 weeks have elapsed and the patient has recovered from all therapy related side effects. Exclusion Criteria: * Life expectancy of less than 3 months * Clinically significant cardiac disease or myocardial infarction within past 6 months * Suspicion or documentation of CNS metastases or carcinomatous meningitis * Psychiatric disability judged by the investigator to be clinically significant, precluding informed consent * Known existing coagulopathy and/or requires therapeutic anticoagulants * Uncontrolled diarrhea * Peripheral neuropathy * Major surgery within 3 weeks of the state of the study treatment without complete recovery * Serious, uncontrolled, concurrent infection * Lack of physical integrity of upper gastrointestinal tract or malabsorption syndrome * Prior severe reaction to fluoropyrimidine, irinotecan or cisplatin * Known interstitial pulmonary fibrosis * Known Gilbert's disease * Uncontrolled diabetes mellitus * Organ allograft(s) on immunosuppressive therapy * Pregnant or lactating women * Patients taking valproic acid
References
Publications (0)
Data not yet available
No reference posted for this study.