Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

This study has been terminated.

(Terminated 4/17/07. Drug sponsor withdrew.)

Sponsor:

Collaborator:

Novartis

Information provided by:

Emory University

ClinicalTrials.gov Identifier:

NCT00209079

First received: September 14, 2005

Last updated: December 27, 2007

Last verified: September 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

December 27, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00209079 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

Official Title ^ICMJE

Phase II Trial of Gleevec (Imatinib Mesylate) and Taxotere (Docetaxel) as a Combined Regimen for Advanced Gastric Adenocarcinoma

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Gastric Adenocarcinoma

Intervention ^ICMJE

Drug: Gleevec, Taxotere

Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks.

Other Name: Imatinib, Mesylate, Docetaxel

Study Arm (s)

Active Comparator: 1

Intervention: Drug: Gleevec, Taxotere

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00209079

Other Study ID Numbers ^ICMJE

0804-2004

Has Data Monitoring Committee

Yes

Responsible Party

John Kauh, MD, Winship Cancer Institute

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Novartis

Investigators ^ICMJE

Principal Investigator:

John Kauh, MD

Emory University Winship Cancer Institute

Information Provided By

Emory University

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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