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

NCT00447967 | Completed Phase 2

• 1 other identifier: CT/04.18
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 8

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

Conditions

Gastric Cancer

Keywords

Metastatic Gastric Cancer; Oxaliplatin; Irinotecan

Outcome Measures

Primary Outcomes (1)

• Objective Response Rates

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

Secondary Outcomes (5)

• Time to progression

  1 year

• Toxicity

  Toxicity assessment on each chemotherapy cycle

• Overall survival

  1 year

• Quality of life

  Assessment every two cycles

• Symptoms improvement

  Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

IOX

Drug: Irinotecan; Drug: Oxaliplatin

2

EXPERIMENTAL

FLOX

Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

Interventions

Irinotecan DRUG

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

Also known as: CPT-11

1

Oxaliplatin DRUG

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

Also known as: LoHP

1

Fluorouracil DRUG

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

Also known as: 5-FU

2

Leucovorin DRUG

Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles

Also known as: LV

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (8)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

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

Athens, Greece

Location

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

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa

Larissa, Greece

Location

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

Piraeus, Greece

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan; Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ioannis Boukovinas, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 15, 2007
• Study Start: July 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 28, 2009

Record last verified: 2009-09

Locations

GR (8)