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Phase I Study of Sunitinib With FOLFIRI (Irinotecan, 5-Fluorouracil and Leucovorin) for Advanced Gastroesophageal Cancers

Phase 1
Open (Enrolling)
Esophageal Cancer, Gastric Cancer

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Trial Information

Phase I Study of Sunitinib With FOLFIRI (Irinotecan, 5-Fluorouracil and Leucovorin) for Advanced Gastroesophageal Cancers



- Determine the maximum tolerated dose of sunitinib malate when administered with FOLFIRI
chemotherapy comprising irinotecan hydrochloride, fluorouracil, and leucovorin calcium
in patients with advanced gastroesophageal cancer.


- Determine the response rates, overall survival, and progression-free survival of
patients treated with this regimen.

- Determine if there is a change in circulating endothelial precursor cell number and
VEGF expression as a result of this therapy and if these changes correlate with
improved response and survival.

- Document any pharmacokinetic interactions between irinotecan hydrochloride and
sunitinib malate.

- Study pharmacokinetics of sunitinib malate on day 14 (steady state) and day 42 (after 6
weeks of continuous dosing).

OUTLINE: 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. Patients also receive FOLFIRI
chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, fluorouracil IV
continuously over 46 hours, and leucovorin calcium IV over 2 hours beginning on days 1 and
15. Treatment repeats every 4 weeks for up to 12 months in the absence of disease
progression or unacceptable toxicity.

Blood is collected at baseline and periodically during study for pharmacokinetic and
biomarker correlative studies. Samples are analyzed by flow cytometry to assess circulating
endothelial cells and VEGF expression.

After completion of study treatment, patients are followed for 4 weeks.

Inclusion Criteria


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


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


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 weeks

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of sunitinib malate when administered with FOLFIRI chemotherapy (i.e., irinotecan hydrochloride, fluorouracil, and leucovorin calcium)

Outcome Time Frame:

30 days after treatment

Safety Issue:


Principal Investigator

Nikhil Khushalani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

October 2013

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the esophagus
  • stage IV esophageal cancer
  • recurrent gastric cancer
  • recurrent esophageal cancer
  • adenocarcinoma of the stomach
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263