Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

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.