Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00237900
• Date of registration: 12/10/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer
• Scientific 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
• Date of first enrolment: July 2003
• Target sample size: 34
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00237900
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Finland

Contacts

• Name: AstraZeneca Oncology Medical Science Director, MD
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

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



Age minimum: 45 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Drug: Gefitinib, 5-fluorouracil, leucovorin and radiotherapy

Primary Outcome(s)

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(s)

Parts 2 and 3:

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

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

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

Secondary ID(s)

1839IL/0539

Source(s) of Monetary Support

Please refer to primary and secondary sponsors