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

Purpose

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	Intervention	Phase
Gastric Cancer	Drug: Irinotecan Drug: Oxaliplatin Drug: Fluorouracil Drug: Leucovorin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Fluorouracil Leucovorin calcium Oxaliplatin Levoleucovorin Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Objective Response Rates [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
Symptoms improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	July 2004
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 IOX	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 FLOX	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

Arms

Assigned Interventions

Experimental: 1

IOX

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

FLOX

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

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447967

Locations

Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
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

Investigators

Principal Investigator:

Ioannis Boukovinas, MD

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

More Information

No publications provided

Responsible Party:	I.Boukovinas, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00447967 History of Changes
Other Study ID Numbers:	CT/04.18
Study First Received:	March 14, 2007
Last Updated:	September 25, 2009
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Metastatic Gastric Cancer
Oxaliplatin
Irinotecan

Additional relevant MeSH terms:

Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 21, 2013