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

Hellenic Oncology Research Group

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Fluorouracil; Drug: Irinotecan; Drug: Oxaliplatin; Drug: Leucovorin

Study type: Interventional

Funder types: Other

Identifiers

NCT00447967

CT/04.18

Details and patient eligibility

About

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

Full 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

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

1

Experimental group

Description:

IOX

Treatment:

Drug: Oxaliplatin

Drug: Irinotecan

Drug: Oxaliplatin

2

Experimental group

Description:

FLOX

Treatment:

Drug: Oxaliplatin

Drug: Leucovorin

Drug: Fluorouracil

Drug: Oxaliplatin