Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach or Gastroesophageal Junction Cancer - Full Text View

Sponsor:	California Cancer Consortium
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068380

Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.

Condition	Intervention	Phase
Esophageal Cancer Gastric Cancer	Drug: imatinib mesylate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate as measured by RECIST every 8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression every 8 weeks [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	41
Study Start Date:	March 2004

Detailed Description:

OBJECTIVES:

Determine the response rate and time to tumor progression in patients with refractory metastatic and/or unresectable adenocarcinoma of the stomach treated with imatinib mesylate.
Determine the overall survival of patients treated with this drug.
Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [chemonaïve] vs poor risk [1 prior chemotherapy regimen]).

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of metastatic and/or unresectable adenocarcinoma of the stomach or gastroesophageal junction
Measurable disease by radiographic imaging
No brain metastasis

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

Karnofsky 70-100%

Life expectancy

More than 3 months

Hematopoietic

Granulocyte count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3
Hemoglobin at least 9 g/dL
No active bleeding disorder

Hepatic

Bilirubin no greater than 1.5 mg/dL
SGOT/SGPT less than 2.5 times upper limit of normal

Renal

Creatinine clearance greater than 60 mL/min

Gastrointestinal

No active peptic ulceration
No active gastrointestinal bleeding

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 3 months after study completion
No active infection
No known seizure disorder
No medical, social, or psychological factors that would preclude completion of study treatment
No serious concurrent illness that would preclude tolerance and completion of study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Recovered from prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Recovered from prior radiotherapy

Surgery

More than 4 weeks since prior major surgery

Other

No concurrent therapeutic warfarin for anticoagulation
No concurrent highly active antiretroviral therapy for HIV-positive patients
No concurrent grapefruit juice

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068380

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

California Cancer Consortium

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Heinz-Josef Lenz, MD

USC/Norris Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000322257, CCC-PHII-37, 2004-01-09, NCI-5734
Study First Received:	September 10, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00068380 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent gastric cancer
stage IV gastric cancer
recurrent esophageal cancer

stage IV esophageal cancer
stage III esophageal cancer
stage III gastric cancer

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib

Neoplasms
Digestive System Diseases
Neoplasms by Site
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on November 27, 2009