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

NCT ID: NCT00447967

Last Updated: 2009-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2008-09-30

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

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

IOX

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles

2

FLOX

Group Type: EXPERIMENTAL

Fluorouracil

Intervention Type: DRUG

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

Leucovorin

Intervention Type: DRUG

Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles

Interventions

Irinotecan

Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles

Intervention Type: DRUG

Fluorouracil

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

Intervention Type: DRUG

Leucovorin

Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles

Intervention Type: DRUG

Other Intervention Names

CPT-11; LoHP; 5-FU; LV; LoHP

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: collaborator

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Hellenic Oncology Research Group

Principal Investigators

Ioannis Boukovinas, MD

Role: PRINCIPAL_INVESTIGATOR

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Locations

University Hospital of Crete

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , 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

Countries

Greece

Other Identifiers

CT/04.18

Identifier Type: -

Identifier Source: org_study_id