Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)

If you are a new GIST patient planning surgery soon, or if you have had your GIST removed within the past 3 months, a new trial to evaluate 5 years of adjuvant imatinib is worth considering if your tumor has a moderate or high risk of recurrence. This trial will test a much longer duration of adjuvant imatinib than the ongoing Z9001 trial (which used one year of adjuvant therapy) or the ongoing Z9000 trial (which used 2 years).

Imatinib lowers the risk of recurrence following surgical removal of GIST as long as the drug is administered, but recurrences have happened after the end of a 1-year or 2-year course of imatinib therapy. The appropriate duration of imatinib therapy following resection is not yet determined. This national trial addresses this important clinical question.

This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA for patients at significant risk for recurrence following complete resection of primary GIST. Participants will take 400 mg of imatinib mesylate daily for a total of 5 years, and then they will be followed for 5 additional years to determine survival, recurrence, and quality of life. Imatinib is available to enrolled patients for 5 years at no cost.

Enrollment is competitive and the trial will be closed after the target of 130 patients is reached.

The follow-up schedule is:

• After the initial screening, 3 times in month # 1 (Day 1, Day 15, Day 29)
• After the first month, every 4 months for the first five years
• After the first 5 years, every 6 months for years 6-10

Inclusion & Exclusion Criteria Highlights

1. Age ≥ 18 years
2. Histological GIST diagnosis and CD117 (KIT) positive tumor 
3. Primary GIST (any site) ≥ 2cm & ≥5 mitoses/50 HPF OR non-gastric primary GIST ≥ 5cm
4. Complete gross resection of primary GIST within 12 weeks of enrollment 
5. No evidence of metastatic GIST on CT or MRI 
6. ECOG performance status of 0 or 1 
7. All prior malignancies treated with potentially curative therapy and free of recurrence for ≥ 3 years 
8. Patients with grade III/IV cardiac problems are excluded 
9. Patients being treated with warfarin are excluded 
10. Patients who have already begun taking imatinib for a brief period prior to enrolling in the study may be accepted.

Locations

25 study locations are listed on the clinicaltrials.gov fact sheet for this trial, but the ones currently open for recruiting are in the following states: Georgia, Idaho, Nevada, New Hampshire, New York, North Carolina, Tennessee, Texas, Rhode Island, and Virginia. The remainder of sites should open soon.

Link for More Details

See NCT00867113 for more information and contacts.

Last changed: Nov 13 2009 at 10:47 AM