Phase 2
N=17
A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
Recurrent Gastric Cancer · Stage IV Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00068380 ↗Enrolled (actual)
17
Serious AEs
47.1%
Results posted
Aug 2014
Primary outcome: Primary: Response Rate — 0 percentage of patients responding
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- imatinib mesylate (Drug); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
— | — |
| PRIMARY Toxicity Summary |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Progression-free Survival |
1.35 | — |
| PRIMARY Overall Survival |
3.25 | — |
| PRIMARY Time to Treatment Failure |
0.98 | — |
| 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 |
— | — |
Summary
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.
Eligibility 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 = 100,000/mm^3
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) 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
Data sourced from ClinicalTrials.gov (NCT00068380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.