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

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Irinotecan

Oxaliplatin

Fluorouracil

Leucovorin

Oxaliplatin

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Metastatic Gastric Cancer, Oxaliplatin, Irinotecan

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University Hospital of Crete
University General Hospital of Alexandroupolis, Dep of Medical Oncology
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
401 Military Hospital of Athens
Air Forces Military Hospital of Athens
State General Hospital of Larissa
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

IOX

FLOX

Outcomes

Primary Outcome Measures

Objective Response Rates

Secondary Outcome Measures

Time to progression

Toxicity

Overall survival

Quality of life

Symptoms improvement

Full Information

NCT ID

NCT00447967

First Posted

March 14, 2007

Last Updated

September 25, 2009

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00447967

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Metastatic Gastric Cancer, Oxaliplatin, Irinotecan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

IOX

Arm Title

Arm Type

Experimental

Arm Description

FLOX

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

CPT-11

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

LoHP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Other Intervention Name(s)

5-FU

Intervention Description

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

Intervention Name(s)

Leucovorin

Other Intervention Name(s)

Intervention Description

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

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

LoHP

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rates

Time Frame

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

Secondary Outcome Measure Information:

Title

Time to progression

Time Frame

1 year

Title

Toxicity

Time Frame

Toxicity assessment on each chemotherapy cycle

Title

Overall survival

Time Frame

1 year

Title

Quality of life

Time Frame

Assessment every two cycles

Title

Symptoms improvement

Time Frame

Assessment every two cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ioannis Boukovinas, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Crete

City

Heraklion

State/Province

Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

University General Hospital of Alexandroupolis, Dep of Medical Oncology

City

Alexandroupolis

Country

Greece

Facility Name

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

City

Athens

Country

Greece

Facility Name

401 Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

Air Forces Military Hospital of Athens

City

Athens

Country

Greece

Facility Name

State General Hospital of Larissa

City

Larissa

Country

Greece

Facility Name

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

City

Piraeus

Country

Greece

12. IPD Sharing Statement

Learn more about this trial

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

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