Stage IV Gastric Cancer Clinical Trial
Official title:
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
Verified date | June 2018 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. 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.
Status | Completed |
Enrollment | 17 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | 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 | |
Primary | Toxicity Summary | 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 | |
Primary | Progression-free Survival | 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 | |
Primary | Overall Survival | 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 | |
Primary | Time to Treatment Failure | 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 | |
Primary | 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 | 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. | Baseline |
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