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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447967
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : September 28, 2009
University Hospital of Crete
Information provided by:
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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Irinotecan Drug: Oxaliplatin Drug: Fluorouracil Drug: Leucovorin Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: 1
Drug: Irinotecan
Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
Other Name: CPT-11
Drug: Oxaliplatin
Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
Other Name: LoHP
Experimental: 2
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
Other Name: 5-FU
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
Other Name: LV
Drug: Oxaliplatin
Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles
Other Name: LoHP

Primary Outcome Measures :
  1. Objective Response Rates [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy) ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: 1 year ]
  2. Toxicity [ Time Frame: Toxicity assessment on each chemotherapy cycle ]
  3. Overall survival [ Time Frame: 1 year ]
  4. Quality of life [ Time Frame: Assessment every two cycles ]
  5. Symptoms improvement [ Time Frame: Assessment every two cycles ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447967

University Hospital of Crete
Heraklion, Crete, Greece, 71110
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
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Ioannis Boukovinas, MD "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Responsible Party: I.Boukovinas, Hellenic Oncology Research Group Identifier: NCT00447967     History of Changes
Other Study ID Numbers: CT/04.18
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: September 28, 2009
Last Verified: September 2009

Keywords provided by Hellenic Oncology Research Group:
Metastatic Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs