Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT00447967
- Lead Sponsor
- Hellenic Oncology Research Group
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Oxaliplatin IOX 1 Irinotecan IOX 2 Fluorouracil FLOX 2 Leucovorin FLOX 2 Oxaliplatin FLOX
- Primary Outcome Measures
Name Time Method Objective Response Rates Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
- Secondary Outcome Measures
Name Time Method Overall survival 1 year Time to progression 1 year Quality of life Assessment every two cycles Symptoms improvement Assessment every two cycles Toxicity Toxicity assessment on each chemotherapy cycle
Trial Locations
- Locations (8)
State General Hospital of Larissa
🇬🇷Larissa, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
🇬🇷Athens, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
🇬🇷Alexandroupolis, Greece
Air Forces Military Hospital of Athens
🇬🇷Athens, Greece
University Hospital of Crete
🇬🇷Heraklion, Crete, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
🇬🇷Piraeus, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
🇬🇷Athens, Greece
401 Military Hospital of Athens
🇬🇷Athens, Greece