First Line Study of Irinotecan, Capecitabine and Oxaliplatin in Metastatic Gastric or Gastroesophageal Cancer. (IXOGoo1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01129310
Recruitment Status : Unknown
Verified January 2016 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
First Posted : May 24, 2010
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasm Gastric Adenocarcinoma Drug: Irinotecan-Capecitabine-Oxaliplatin Phase 2

Detailed Description:
This is a single arm, open-label, multicentre, phase II trial in which patients with metastatic gastric or GEJ adenocarcinoma will be treated with the combination of irinotecan, capecitabine, and oxaliplatin (IXO).Patients will receive the combination of irinotecan, capecitabine, and oxaliplatin at the recommended phase II dose and sequence determined by the completed phase I trial. Patients will be treated on study until disease progression, overwhelming toxicity, or consent withdrawal.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open-label Phase II Study of Irinotecan, Capecitabine(Xeloda), and Oxaliplatin (IXO) as First Line Treatment in Patients With Metastatic Gastric or Gastroesophageal (GEJ) Adenocarcinoma.
Study Start Date : July 2010
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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
    Other Name: Camptosar; Xeloda; Eloxatin

Primary Outcome Measures :
  1. Overall Response Rate and dose limiting toxicity [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression Free Survival, overall survival, death, alterations in quality of life outcomes [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histologically documented gastric GEJ adenocarcinoma not previously treated with palliative systemic therapy.
  • Metastatic disease based on the presence of clinically and/or radiologically documented measurable disease based on RECIST.
  • ECOG performance status of 0,1 or 2.
  • Age ≥ 18 years
  • Life expectancy of least 3 months based on discretion of treating oncologist.
  • Adequate hematologic, hepatic, and renal function.
  • Patients who have received prior chemotherapy or radiation delivered as part of initial curative therapy (i.e. neoadjuvant or adjuvant chemotherapy administered alone and/or concurrently delivered with radiation and/or surgery) are permitted as long as that treatment was completed at least 6 months prior to study start date.
  • Patients may have received prior palliative radiotherapy (unless radiation was curative therapy to pelvis or to ≥25% of bone marrow stores) if this radiation was ≥ 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.
  • Patients may have received prior surgery if this surgery was ≥ 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.
  • Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.

Exclusion Criteria:

  • Patients who have received palliative chemotherapy for their metastatic gastric or GEJ tumor.
  • Prior treatment with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, prior treatment with irinotecan or oxaliplatin chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy.
  • Curative radiation treatment to the pelvis or radiation therapy to ≥ 25% of bone marrow stores.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases.
  • Previous of concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured.
  • Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure,unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that .....
  • Gilbert's disease
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Pre-existing neuropathy ≥ grade 2 from any cause.
  • Patients with unstable metastasis to the central nervous system are excluded. Patients who have treated brain metastasis and are off steroids, anticonvulsants, and have documented stability of lesions for at least 3 months may be eligible. A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement.
  • Pregnant of lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01129310

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Study Chair: Jennifer Spratlin, MD Alberta Health Services

Responsible Party: AHS Cancer Control Alberta Identifier: NCT01129310     History of Changes
Other Study ID Numbers: IXOGoo1 25412
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016

Keywords provided by AHS Cancer Control Alberta:
health-related quality of life
gastroesophageal(GE) junction adenocarcinoma

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors