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Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
Phase 2 trial testing Conventional Surgery in Gastrointestinal Stromal Tumor in 63 participants. Completed in 28 January 2009.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 63 |
| Start date | 31 March 2002 |
| Primary completion | 28 January 2009 |
| Estimated completion | 28 January 2009 |
| Sites | 1 location across United States |
National Cancer Institute (NCI)
18 and older, any sex, with Gastrointestinal Stromal Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Kaplan-Meier estimate of disease progression rate. Disease progression is determined by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf
| Group | Value | 95% CI |
|---|---|---|
| Imatinib Mesylate | 13.8 | 4.2 – 23.4 |
The percentage of patients who achieved a complete, partial or stable response prior to surgery as assessed by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf.
| Group | Value | 95% CI |
|---|---|---|
| Imatinib Mesylate | 0 | 0 – 0 |
| Group | Value | 95% CI |
|---|---|---|
| Imatinib Mesylate | 5.8 | 1.2 – 15.9 |
| Group | Value | 95% CI |
|---|---|---|
| Imatinib Mesylate | 86.5 | 74.2 – 94.4 |
Highest grade toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity, using Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.
| Group | Value | 95% CI |
|---|---|---|
| Imatinib Mesylate | 34.6 | 22.0 – 49.1 |
| Group | Value | 95% CI |
|---|---|---|
| Imatinib Mesylate | 48.9 | 33.7 – 64.2 |
evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax \<1 indicate decreased tumor metabolism while values \>1 indicated an increase in tumor metabolism. Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabo
| Group | Value | 95% CI |
|---|---|---|
| PET Patricipants | -59.4 | -100 – 81.4 |
Time frame: Adverse event (AE) information is collected Weeks 1, 4, 8, Months 3,8,9, then every 3 months until 2 years, then every 6 months until 5 years, then annually. (SAE = Serious Adverse Event).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Imatinib Mesylate |
|---|---|---|
| Infections and infestations - Other | Infections and infestations | — |
| Neutrophil count decreased | Investigations | — |
| Wound infection | Infections and infestations | — |
| Capillary leak syndrome | Vascular disorders | — |
| Thromboembolic event | Vascular disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Cardiac disorders - Other | Cardiac disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Esophageal fistula | Gastrointestinal disorders | — |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | — |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| General disorders and administration site conditions - Other | General disorders | — |
| Serum amylase increased | Investigations | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Intracranial hemorrhage | Nervous system disorders | — |
| Peripheral motor neuropathy | Nervous system disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Imatinib Mesylate |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Capillary leak syndrome | Vascular disorders | — |
| White blood cell decreased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Neutrophil count decreased | Investigations | — |
| Fatigue | General disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Pain | General disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Alkaline phosphatase increased | Investigations | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Watering eyes | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Blood bilirubin increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Infections and infestations - Other | Infections and infestations | — |
| Weight loss | Investigations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Creatinine increased | Investigations | — |
| Weight gain | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Flatulence | Gastrointestinal disorders | — |
| Investigations - Other | Investigations | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Conjunctivitis | Eye disorders | — |
Most-reported serious reactions: Infections and infestations - Other, Neutrophil count decreased, Wound infection, Capillary leak syndrome, Thromboembolic event, Febrile neutropenia, Anorexia, Dizziness.
Data from ClinicalTrials.gov NCT00028002 adverse events section.
Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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