Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00237900

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 I Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

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

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

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

Study ID Numbers:	1839IL/0539
Study First Received:	October 12, 2005
Last Updated:	October 12, 2005
ClinicalTrials.gov Identifier:	NCT00237900
Health Authority:	Finland: National Agency for Medicines

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil

Stomach Neoplasms
Leucovorin
Gastrointestinal Neoplasms
Stomach cancer
Gefitinib

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Protein Kinase Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009