- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00068380
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the response rate, time to tumor progression, and overall survival in patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy regimen for metastatic disease.
II. To assess the toxicities of STI571 in these patients. III. To obtain preliminary data on molecular correlates to determine clinical efficacy and toxicity.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with metastatic and/or unresectable carcinoma of the stomach, who have measurable disease
- Life expectancy > 3 months
- Karnofsky Performance Status > 60%
- Absence of an active infection
- Granulocyte count of > 1,500/mm^3
- Hemoglobin (Hgb) >= 9 mg/dl
- Serum bilirubin =< 1.5 mg/dl, regardless of liver involvement secondary to tumor
- Platelets > 100,000/mm^3
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x the institutional upper limit of normal
- Calculated creatinine clearance of > 60 ml/min
- Patients must have signed written informed consent
- Female patients of child-bearing potential must have a negative blood or urine pregnancy test within two weeks prior to initial study treatment
- Patients who have had prior chemotherapy or radiation therapy must have recovered from any toxicities prior to study entry
- Patients must have radiographic imaging to document measurable disease within 28 days prior to initial study therapy
Exclusion Criteria:
- Diagnosis of resectable carcinoma of the stomach
- Major surgery within four weeks of study entry
- Brain metastasis or known seizure disorder
- Fertile men and women not using an acceptable method of contraception
- Pregnant or lactating patients are excluded since STI571 may be harmful to the developing fetus and child
- Patients known to be HIV positive and receiving HAART are excluded because of possibly pharmacological interactions
- Active peptic ulceration or active gastrointestinal bleeding or any active bleeding disorders
- Use of therapeutic doses of coumadin (warfarin) as anticoagulation
- Medical, social, or psychological factors which would prevent the patient from completing the treatment protocol
- Patients with serious intercurrent illness which would preclude tolerance and completion of the protocol treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (imatinib mesylate)
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.
|
Correlative studies
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: Up to 6 years
|
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by X-Ray, MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
|
Up to 6 years
|
Toxicity Summary
Time Frame: Up to 30 days post treatment
|
Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 2.0.
Grade 3 and above adverse events possibly, probably or definitely related to treatment.
|
Up to 30 days post treatment
|
Progression-free Survival
Time Frame: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 30 days post treatment
|
Estimated using the product-limit method of Kaplan and Meier.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
|
From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 30 days post treatment
|
Overall Survival
Time Frame: From first day of treatment to time of death due to any cause, assessed up to 5 years post-treatment
|
Will be summarized using the Kaplan-Meier product-limit estimators.
|
From first day of treatment to time of death due to any cause, assessed up to 5 years post-treatment
|
Time to Treatment Failure
Time Frame: From first day of treatment until discontinuation of treatment, assessed up to 30 days post treatment
|
Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
|
From first day of treatment until discontinuation of treatment, assessed up to 30 days post treatment
|
Baseline Gene Expression Levels of the Target Genes (PDGF-R and PDGF), Genes Associated With Induction of Apoptosis (Bcl-2, Bax), and Cell Cycle Regulatory Genes (p53, p21, p27
Time Frame: Baseline
|
Will summarized overall and according to response and toxicity (if numbers permit), using medians, quartiles and ranges - or if a transformation is found to render the data compatible with the normal assumptions, with means, standard deviations, and confidence intervals.
The association with progression-free survival or overall survival will be assessed by dichotomizing the measures of gene expression at the median (or by previously established cut-points) and constructing Kaplan-Meier plots.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heinz-Josef Lenz, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02825
- N01CM62209 (U.S. NIH Grant/Contract)
- 5734
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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