Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00237900
• Other study ID #: 1839IL/0539
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: October 12, 2005
• Last updated: April 22, 2009
• Start date: July 2003
• Est. completion date: February 2004

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Gefitinib, 5-fluorouracil, leucovorin and radiotherapy

Locations

Country	Name	City	State
Finland	Reseach Site	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
Primary	Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy
Secondary	Parts 2 and 3:
Secondary	Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).
Secondary	Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores
Secondary	Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509