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Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

Primary Purpose

Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC

Status

Terminated

Phase

Phase 1

Locations

Finland

Study Type

Interventional

Intervention

Gefitinib, 5-fluorouracil, leucovorin and radiotherapy

About this trial

This is an interventional treatment trial for Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically-confirmed intestinal GC (T2-T4) Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction Lymph node positive or negative Metastasis negative Resection with curative intent (R0, D2) Chemo- and radiotherapy naïve Measurable lesion according RECIST Written informed consent Exclusion Criteria: Aged below 45 or over 70 Prior gastric surgery Active ILD

Sites / Locations

Reseach Site

Outcomes

Primary Outcome Measures

Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)

Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy

Secondary Outcome Measures

Parts 2 and 3:

Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).

Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores

Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509

Full Information

NCT ID

NCT00237900

First Posted

October 12, 2005

Last Updated

April 22, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00237900

Brief Title

Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

Official Title

An Open, Single.Centre, Phase I/II Study of ZD1839 (Iressa) in Combination With 5-Fluorouracil, Leucovorin and Radiotherapy in Subjects With Resectable Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Terminated

Study Start Date

July 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer

6. Conditions and Keywords

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

Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

34 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gefitinib, 5-fluorouracil, leucovorin and radiotherapy

Primary Outcome Measure Information:

Title

Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)

Title

Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy

Secondary Outcome Measure Information:

Title

Parts 2 and 3:

Title

Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).

Title

Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores

Title

Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AstraZeneca Oncology Medical Science Director, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Reseach Site

City

Helsinki

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

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