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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: Pfizer
• Treatments: Calcium; Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Sunitinib

Criteria

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 weeks