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

NCT00524186 | Terminated Phase 1 DMC

• 2 other identifiers: CDR0000562762RPCI-I-69605
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  30 days after treatment

Secondary Outcomes (7)

• Toxicity

  28 days

• Response rate as assessed by RECIST criteria

  Every 3 months up to 5 years

• Progression-free survival

  Every 3 months up to 5 years

• Overall survival

  up to 5 years

• Circulating endothelial precursor cell (CEC) number

  At baseline

Study Arms (1)

Oral Sunitinib

EXPERIMENTAL

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

Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: sunitinib malate; Other: flow cytometry; Other: pharmacological study

Interventions

fluorouracil DRUG

Given IV

Oral Sunitinib

irinotecan hydrochloride DRUG

Given IV

Oral Sunitinib

leucovorin calcium DRUG

Given IV

Oral Sunitinib

sunitinib malate DRUG

Taken Orally

Oral Sunitinib

flow cytometry OTHER

Correlative Study

Oral Sunitinib

pharmacological study OTHER

Correlative Study

Oral Sunitinib

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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:
• 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
• Uncontrolled infection
• Uncontrolled serious medical disease
• Uncontrolled hypertension
• Coagulopathy or bleeding disorder

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Pfizer: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (1)

• 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.

  PMID: 31802410 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

Fluorouracil; Irinotecan; Leucovorin; Sunitinib; Flow Cytometry

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Pyrroles; Azoles; Indoles; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Patrick Boland, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: April 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2016-06

Locations

US (1)