Clinical trial · Interventional
Sunitinib, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal Cancer
Phase I Study of Sunitinib With FOLFIRI (Irinotecan, 5-Fluorouracil and Leucovorin) for Advanced Gastroesophageal Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institute
Summary
Brief summary (as posted)
RATIONALE: Sunitinib 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 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 sunitinib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib when given together with irinotecan, fluorouracil, and leucovorin in treating patients with advanced stomach cancer or gastroesophageal cancer.
Conditions
Conditions (2)
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 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| sunitinib malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Sunitinib
- description
- Patients receive oral sunitinib malate on day -7 and then once daily on days 2-28 in course 1 and on days 1-28 in all subsequent courses
- interventionNames
- Drug: fluorouracil
- Drug: irinotecan hydrochloride
- Drug: leucovorin calcium
- Drug: sunitinib malate
- Other: flow cytometry
- Other: pharmacological study
Primary outcomes (1)
- measure
- Maximum tolerated dose of sunitinib malate when administered with FOLFIRI chemotherapy (i.e., irinotecan hydrochloride, fluorouracil, and leucovorin calcium)
- timeFrame
- 30 days after treatment
Secondary outcomes (7)
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
Inclusion criteria:
* Histologically confirmed diagnosis of 1 of the following:
* Locally advanced or unresectable gastric cancer
* Metastatic gastric adenocarcinoma
* Metastatic gastroesophageal junction (GEJ) adenocarcinoma
* Esophageal adenocarcinomas with involvement of GEJ allowed
Exclusion criteria:
* Symptomatic, uncontrolled CNS metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-1
* Life expectancy \> 12 weeks
* WBC ≥ 3,000/μL
* Platelet count ≥ 100,000/μL
* Creatinine ≤ 1.5 mg/dL
* Bilirubin ≤ 1.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Exclusion criteria:
* Uncontrolled infection
* Uncontrolled serious medical disease
* Uncontrolled hypertension
* Coagulopathy or bleeding disorder
* History of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate or other agents used in study
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* No prior chemotherapy for metastatic disease
* Concurrent therapeutic anticoagulation allowed
Exclusion criteria:
* Other concurrent investigational therapy
* Concurrent combination antiretroviral therapy in HIV-positive patients
* Major surgery or radiotherapy within the past 3 weeksReferences
Publications (1)
- DERIVEDMukherjee S, Fountzilas C, Boland PM, Gosain R, Attwood K, Tan W, Khushalani N, Iyer R. Phase I Study of Irinotecan/5-Fluorouracil/Leucovorin (FOLFIRI) with Sunitinib for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. Target Oncol. 2020 Feb;15(1):85-92. doi: 10.1007/s11523-019-00692-y. PMID 31802410