Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

NCT00514020 | Completed Phase 2 Results DMC

• 3 other identifiers: VICC GI 0716P30CA068485VU-VICC-GI-0716
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, 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 more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.

Conditions

Gastric Cancer

Keywords

adenocarcinoma of the stomach; stage IV gastric cancer; recurrent gastric cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])

  Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.

  every 8 weeks to progression

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Genetic: gene expression analysis; Genetic: polymorphism analysis; Genetic: protein expression analysis; Other: pharmacological study

Interventions

fluorouracil DRUG

Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.

Treatment

leucovorin calcium DRUG

through a vein over 2 hours on days 1 and 15.

Treatment

oxaliplatin DRUG

500 ml D5W through a vein over 2 hours on days 1 and 15.

Treatment

gene expression analysis GENETIC

Blood collection

Treatment

polymorphism analysis GENETIC

Blood collection

Treatment

protein expression analysis GENETIC

Blood collection

Treatment

pharmacological study OTHER

Blood collection

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
• Metastatic disease
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
• No known active brain metastases
• Patients with treated brain metastases are eligible if stable off steroids for at least 30 days
• PATIENT CHARACTERISTICS:
• ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)
• Life expectancy ≥ 3 months
• WBC ≥ 3,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• AST or ALT ≤ 2.5 x ULN (\< 5 x ULN if known liver metastases)
• Creatinine clearance ≤ 1.5 x ULN
• Not pregnant or nursing

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Genetic Techniques; Investigative Techniques; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Results Point of Contact

• Title: Laura Goff, MD
• Organization: Vanderbilt-Ingram Cancer Center

laura.goff@vanderbilt.edu

615-936-0059

Study Officials

• Laura W. Goff, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 1, 2012
• Results First Posted: October 18, 2012

Record last verified: 2012-10

Locations

US (5)