A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068380
First received: September 10, 2003
Last updated: June 4, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Gastric Cancer Stage IV Gastric Cancer |
Drug: imatinib mesylate Other: laboratory biomarker analysis Other: pharmacogenomic studies |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Tumor response as determined by the RECIST criteria [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]Will be calculated as the percent of evaluable patients whose best response is a CR or PR, and exact 95% confidence intervals will be calculated for this estimate.
- Toxicity in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by NCI Common Toxicity Criteria and nadir or maximum values for the laboratory measures), time of onset, duration, and reversibility [ Time Frame: Up to 30 days post treatment ] [ Designated as safety issue: Yes ]Tables will be created to summarize these toxicities by type and severity. Baseline information (e.g. the extent of prior therapy) and demographic information will be presented, as well, to describe the patients treated in this Phase II study.
- 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 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From first day of treatment to time of death due to any cause, assessed up to 30 days post-treatment ] [ Designated as safety issue: No ]Will be summarized using the Kaplan-Meier product-limit estimators.
- Time to progression [ Time Frame: From first day of treatment to the first observation of disease progression or death due to disease, assessed up to 6 years ] [ Designated as safety issue: No ]Will be summarized using the Kaplan-Meier product-limit estimators.
- 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 41 |
| Study Start Date: | March 2004 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: imatinib mesylate
Given orally
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacogenomic studies
Correlative studies
Other Name: Pharmacogenomic Study
|
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068380 History of Changes |
| Other Study ID Numbers: | NCI-2012-02825, 5734, N01CM62209 |
| Study First Received: | September 10, 2003 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013