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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447967
• Other study ID #: CT/04.18
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2007
• Last updated: September 25, 2009
• Start date: July 2004
• Est. completion date: September 2008

Study information

• Verified date: September 2009
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Irinotecan
Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles
• Oxaliplatin
Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles
• 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
• 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
• Oxaliplatin
Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles

Locations

Country	Name	City	State
Greece	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	University Hospital of Crete	Heraklion	Crete
Greece	State General Hospital of Larissa	Larissa
Greece	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Piraeus

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rates		Objective responses confirmed by CT or MRI (on 3rd and 6th cy)	No
Secondary	Time to progression		1 year	No
Secondary	Toxicity		Toxicity assessment on each chemotherapy cycle	Yes
Secondary	Overall survival		1 year	No
Secondary	Quality of life		Assessment every two cycles	No
Secondary	Symptoms improvement		Assessment every two cycles	No