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

Sponsor
AHS Cancer Control Alberta
Study ID
NCT01129310
Phase
PHASE2
Status
Completed

Conditions

  • Gastric Adenocarcinoma
  • Gastrointestinal Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan-Capecitabine-Oxaliplatin — DRUG
    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

Study Details

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

Key Dates

Start date
Jul 31, 2010
Status verified
Jan 2016
Primary completion
May 18, 2018
Completion
May 18, 2018

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Overall Response Rate and dose limiting toxicity [ Time Frame: 2 years ]

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