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

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Irinotecan; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin

• 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

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-14
• Study First Posted: 2007-03-15
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-25
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

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)

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

State General Hospital of Larissa; 🇬🇷 Larissa, Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece