Status:
COMPLETED
Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
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 combin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00447967
Start Date
July 1 2004
End Date
September 1 2008
Last Update
September 28 2009
Active Locations (8)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece