Combination of CPT-11 and LoHP vs Combination of 5-FU, Le... | NCT00447967

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Mar 14, 2007

First Submission Date that Met QC Criteria

Mar 14, 2007

First Posted Date

Mar 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2009

Last Update Posted Date

Sep 28, 2009Estimated

Name	Class
University Hospital of Crete	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	IOX	Drug: Irinotecan Drug: Oxaliplatin
2	Experimental	FLOX	Drug: Fluorouracil Drug: Leucovorin Drug: Oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irinotecan	Drug	Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles	1

Measure	Description	Time Frame
Objective Response Rates		Objective responses confirmed by CT or MRI (on 3rd and 6th cy)

Measure	Description	Time Frame
Time to progression		1 year
Toxicity		Toxicity assessment on each chemotherapy cycle
Overall survival

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ioannis Boukovinas, MD	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Crete		Heraklion	Crete	71110	Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology

ID	Term
D013274	Stomach Neoplasms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases

ID	Term
D000077146	Irinotecan
D000077150	Oxaliplatin
D005472	Fluorouracil
D002955	Leucovorin

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes