Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

This study has been terminated.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00237900
First received: October 12, 2005
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC
Drug: Gefitinib, 5-fluorouracil, leucovorin and radiotherapy
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 34
Study Start Date: July 2003
Study Completion Date: February 2004
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237900

Locations
Finland
Reseach Site
Helsinki, Finland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Oncology Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00237900     History of Changes
Other Study ID Numbers: 1839IL/0539
Study First Received: October 12, 2005
Last Updated: April 22, 2009
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Gefitinib
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014