Imatinib In Adjuvant GIST
- Conditions
- Health Condition 1: null- Primary Gastrointestinal Stromal Tumor (GIST)
- Registration Number
- CTRI/2009/091/000506
- Lead Sponsor
- ovartis India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
1. Histologically proven diagnosis of primary GIST (without peritoneal or distant metastasis) with positive immunostaining for KIT (CD117);
2. Undergone complete gross resection of a primary GIST within 70 days prior to enrollment (includes R0 (negative microscopic margins) and R1 (positive microscopic margins);
3. Intermediate and high risk patients based on Corless criteria
4. Patient must be 18 years of age or older
5. WHO performance status 0 or 1 (Appendix 1)
6. Patient must have a post-operative CT scan with IV and PO contrast or MRI (optional) with contrast (if allergic to CT contrast) of abdomen and pelvis within 28 days prior to registration.
7. Patient must have the following post-operative laboratory values confirmed within 14 days prior to registration:
a. Creatinine ≤ 1.5 times the institution ULN (upper limit of normal)
b.WBC ≥ 2,000/mm3
c.Platelets ≥ 100,000/mm3
d.Total Bilirubin ≤ 1.5 times the institution ULN.
NOTE:Patients with elevated bilirubin secondary to Gilbert?s disease are eligible to participate in the study.
e.AST ≤ 2.5 times the institution ULN
f.ALT ≤ 2.5 times the institution ULN
g.Female of childbearing potential must have negative serum pregnancy test.
NOTE:Post-menopausal women must be amenorrheic for at least 12 months to be deemed not of reproductive potential.
8. Patient or the patient?s legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
9. Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration (non-US sites are exempt from HIPAA regulations).
10. If patient is a cancer survivor, ALL of the following criteria apply:
a.Patient has undergone potentially curative therapy for all prior malignancies.
b.No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone).
c. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
1. Patient has received post-operative chemotherapy.
2. Patient has received post-operative radiation therapy.
3. Patient has received post-operative investigational treatment.
4. Patient has received prior therapy with imatinib, or any other molecular targeted or biological therapy.
5. Patient has had an active infection requiring antibiotics within 14 days prior to registration.
6. Patient has objective evidence of residual disease on the postoperative CT scan or MRI (optional) of the abdomen or pelvis.
7. Patient, if female and breastfeeding. NOTE: It is not known whether imatinib or its metabolites are excreted in human milk. However, in lactating female rats administered 100mg/kg, a dose approximately equal to the maximum clinical dose of 800mg/day based on body surface area, imatinib and /or its metabolites were extensively excreted in milk. It is estimated that approximately 1.5% of a maternal dose is excreted into milk, which is equivalent to a dose to the infant of 30% the maternal dose per unit body weight. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should be advised against breastfeeding while taking imatinib.
8. Patient has New York Heart Association Class 3 or 4 cardiac disease (Appendix 3)
9. Patient is taking full dose warfarin. NOTE: The use of mini-dose warfarin (1 mg orally per day) for prevention of central line-associated deep venous thrombosis is permitted.
10. Presence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection, such as HIV infection, etc.).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess Recurrence Free Survival Rate in patients with resected primary GIST who are<br>treated with adjuvant imatinib for a duration of 2 yearsTimepoint: 2 Years
- Secondary Outcome Measures
Name Time Method - To compare Recurrence Free Survival, Overall Survival, and Time to<br>Recurrence of patients with resected primary GIST who are treated<br>with adjuvant imatinib for a duration of 2 years with historical data<br><br><br><br><br>- To assess the safety of imatinib given as adjuvant therapy for 2<br>years in patients with resected primary GISTTimepoint: 2 Years