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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by AHS Cancer Control Alberta
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01129310
First received: May 21, 2010
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Gastrointestinal Neoplasm
Gastric Adenocarcinoma
Drug: Irinotecan-Capecitabine-Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Overall Response Rate and dose limiting toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression Free Survival, overall survival, death, alterations in quality of life outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129310

Contacts
Contact: Jennifer Spratlin, MD 780-432-8513 Jennifer.Spratlin@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Jennifer Spratlin, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Sanofi
Investigators
Study Chair: Jennifer Spratlin, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01129310     History of Changes
Other Study ID Numbers: IXOGoo1 25412
Study First Received: May 21, 2010
Last Updated: February 28, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Irinotecan
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 26, 2014