Gastric Cancer
Conditions
Keywords
Metastatic Gastric Cancer, Oxaliplatin, Irinotecan
Brief summary
This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer
Detailed description
There is no regimen considered standard in advanced gastric cancer. The reported response rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable toxicity. Irinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a synergistic activity with LOHP in preclinical trials
Interventions
DRUGIrinotecan
Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
DRUGOxaliplatin
Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
DRUGFluorouracil
Fluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles
DRUGLeucovorin
Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed locally advanced or metastatic gastric cancer. * Measurable or evaluable disease. * Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease. * Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study. * Karnofsky performance status \> 70%. * Age ≥18 years. * Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function. * Patients must be able to understand the nature of this study and give written informed consent.
Exclusion criteria
* Active infection * History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow. * Patients with CNS metastases * Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction. * Malnutrition or loss of \> 10% of body weight during the last month. * Peripheral neuropathy ≥ grade 2 * Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer. * Psychiatric illness or social situation that would preclude study compliance. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rates | Objective responses confirmed by CT or MRI (on 3rd and 6th cy) |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | 1 year |
| Toxicity | Toxicity assessment on each chemotherapy cycle |
| Overall survival | 1 year |
| Quality of life | Assessment every two cycles |
| Symptoms improvement | Assessment every two cycles |
Countries
Greece
Outcome results
None listed