Clinical trial · Interventional
Vorinostat, Irinotecan, Fluorouracil, and Leucovorin in Treating Patients With Advanced Upper Gastrointestinal Cancer
Phase I Study of Vorinostat [Suberoylanilide Hydroxamic Acid (VORINOSTAT)] With Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (FOLFIRI) for Advanced Upper Gastrointestinal Cancers
- 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: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced upper gastrointestinal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) of vorinostat (SAHA) when administered continuously and intermittently with standard doses of irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI)
- timeFrame
- 4 weeks
- measure
- Recommended phase II dose (RPTD) of SAHA when administered continuously and intermittently with standard doses of FOLFIRI
- timeFrame
- 4 weeks
Secondary outcomes (5)
- measure
- Toxicity of the SAHA and FOLFIRI combination
- timeFrame
- Baseline and after 2 weeks of Treatment
- measure
- Effects of SAHA and FOLFIRI combination on TGF-β signaling and survivin expression
- timeFrame
- Every 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed upper gastrointestinal tract cancer, including any of the following: * Esophageal cancer (adenocarcinoma or squamous cell carcinoma) * Gastric cancer (adenocarcinoma or squamous cell carcinoma) * Hepatocellular carcinoma * Locally advanced, inoperable disease or metastatic disease * No uncontrolled brain metastases PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 (Karnofsky PS ≥ 70%) * Life expectancy \> 12 weeks * Platelet count ≥ 100,000/mcL * Absolute neutrophil count ≥ 1,500/mcL * Leukocytes ≥ 3,000/mcL * Total bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to understand and willing to sign a written informed consent document * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA) or other agents used in the study * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Uncontrolled hypertension * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * No coagulopathy or bleeding disorder * No known UGT1A1 polymorphism PRIOR CONCURRENT THERAPY: * No more than 1 prior chemotherapy for metastatic disease * No prior histone deacetylase inhibitors * No concurrent prophylactic hematologic growth factors * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent valproic acid * No other concurrent investigational therapy * Concurrent therapeutic anticoagulation therapy is allowed
References
Publications (0)
Data not yet available