Sunitinib, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal Cancer
Stopped early · Phase 1
Conditions studied: Esophageal Cancer, Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT00524186
- Run by
- Roswell Park Cancer Institute
- People needed
- 23
- Starts
- 2007-05-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-06-21
Who can join
Age: any, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Roswell Park Cancer Institute — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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