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.
- 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
- 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.
- Patients who have received palliative chemotherapy for their metastatic gastric or
- 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
- Curative radiation treatment to the pelvis or radiation therapy to ≥ 25% of bone
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption
syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal
- 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