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First Line Study of Irinotecan, Capecitabine and Oxaliplatin in Metastatic Gastric or Gastroesophageal Cancer.

NCT01129310 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-02-25

No results posted yet for this study

Summary

The investigators hypothesize IXO chemotherapy will have an improvement in response rate and acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls.

Conditions

  • Gastrointestinal Neoplasm
  • Gastric Adenocarcinoma

Interventions

DRUG

Irinotecan-Capecitabine-Oxaliplatin

Irinotecan-160mg/m2 IV infusion over 60-90 min on Day 1 Capecitabine-1900mg/m2 daily PO in divided doses (=950mg/m2 BID) on days 2-15 Oxaliplatin- 100mg/m2 IV infusion over 2 hours Day 1

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • Jennifer Spratlin, MD · Alberta Health services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2018-05-18
Completion
2018-05-18

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129310 on ClinicalTrials.gov