Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma - Full Text View

Sponsors and Collaborators:	Emory University Novartis
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00209079

Purpose

The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

Condition	Intervention	Phase
Gastric Adenocarcinoma	Drug: Gleevec, Taxotere	Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Docetaxel Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Gleevec (Imatinib Mesylate) and Taxotere (Docetaxel) as a Combined Regimen for Advanced Gastric Adenocarcinoma

Further study details as provided by Emory University:

Primary Outcome Measures:

Determine if combination of Gleevec and Taxotere is effective treatment for incurable stomach cancer. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine toxicity of combination of Gleevec and Taxotere. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment:	5
Study Start Date:	September 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Gleevec, Taxotere Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks.

Detailed Description:

The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. Gleevec is a pill form of chemotherapy and is indicated for the treatment of adult patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is considered experimental for the treatment of stomach cancer. Taxotere (docetaxel) is a chemotherapy which is injected into the vein. It is approved for breast and lung cancer but has been shown to shrink many different types of tumors. Taxotere has been shown to shrink stomach cancer in about 20% - 30% of patients treated with Taxotere only. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

Treatment on this study consists of two drugs, Gleevec® and Taxotere. Patients will be take four tablets of Gleevec® daily throughout the study. After one week of Gleevec®, patients will then begin receiving doses of Taxotere intravenously once a week for two weeks in a row followed by one week without Taxotere.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

This study is for patients with histologically confirmed unresectable gastric adenocarcinoma and who have not received any chemotherapy other than 5-FU for adjuvant therapy either alone or in conjunction with radiation.

Exclusion Criteria:

Patients may not have received any chemotherapy agents other than 5-FU.
Patients may not have received 5-FU for for therapy for metastatic gastric cancer.
Patients must be more than 5 years free of another primary malignancy except: if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
Patients must not have Grade III/IV cardiac problems, or any severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
Patient must not have had previously received radiotherapy to >/= 25% of the bone marrow, or have had major surgery within 2 weeks prior to study entry
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209079

Locations

United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Novartis

Investigators

Principal Investigator:

John Kauh, MD

Emory University Winship Cancer Institute

More Information

Responsible Party:	Winship Cancer Institute ( John Kauh, MD )
Study ID Numbers:	0804-2004
Study First Received:	September 14, 2005
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00209079
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Gastric Adenocarcinoma

Study placed in the following topic categories:

Imatinib
Docetaxel
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009