Sunitinib, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal Cancer

NCT00524186

Last updated date
Study Location
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Esophageal Cancer, Gastric Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-120
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Other concurrent investigational therapy


- Concurrent combination antiretroviral therapy in HIV-positive patients


- Major surgery or radiotherapy within the past 3 weeks

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Esophageal Cancer, Gastric CancerSunitinib, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal Cancer
NCT00524186
  1. Buffalo, New York
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sunitinib, Irinotecan, Fluorouracil, and Leucovorin In Treating Patients With Advanced Stomach Cancer or Gastroesophageal Cancer
Official Title  ICMJE Phase I Study of Sunitinib With FOLFIRI (Irinotecan, 5-Fluorouracil and Leucovorin) for Advanced Gastroesophageal Cancers
Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Cancer
  • Gastric Cancer
Intervention  ICMJE
  • Drug: fluorouracil
    Given IV
  • Drug: irinotecan hydrochloride
    Given IV
  • Drug: leucovorin calcium
    Given IV
  • Drug: sunitinib malate
    Taken Orally
  • Other: flow cytometry
    Correlative Study
  • Other: pharmacological study
    Correlative Study
Study Arms  ICMJE Experimental: Oral Sunitinib
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
Interventions:
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
  • Drug: sunitinib malate
  • Other: flow cytometry
  • Other: pharmacological study
Publications * Mukherjee 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 5, 2015)
23
Original Enrollment  ICMJE
 (submitted: August 31, 2007)
30
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/?L
  • Platelet count ? 100,000/?L
  • 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 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00524186
Other Study ID Numbers  ICMJE CDR0000562762
RPCI-I-69605
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Patrick Boland, MDRoswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP