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A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rates

Outcome Time Frame:

Objective responses confirmed by CT or MRI (on 3rd and 6th cy)

Safety Issue:

No

Principal Investigator

Ioannis Boukovinas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Greece: National Organization of Medicines

Study ID:

CT/04.18

NCT ID:

NCT00447967

Start Date:

July 2004

Completion Date:

September 2008

Related Keywords:

  • Gastric Cancer
  • Metastatic Gastric Cancer
  • Oxaliplatin
  • Irinotecan
  • Stomach Neoplasms

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