MDACC Study Summary 2009-0296

Study Summary
No. 2009-0296:.......GIST......Dejka M. Araujo......Sarcoma Medical Oncology

Study Summary Title



Study Summary Number:	2009-0296

Study Title:	A Phase II, non-randomized, open-label multicenter study of 5 year adjuvant imatinib mesylate (Gleevec®) in patients at significant risk for recurrence following complete resection of primary gastrointestinal stromal tumor (GIST)

Physician

New Patient Referral



Name:	Dejka M. Araujo	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Sarcoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3626 Contact us about clinical trials

General Information



Disease Group:	GIST	Supported By:	Novartis

Phase of Study:	Phase II	Return Visit:	Screening, Day1, Day 15, Day 29, then every 4 mos for next 5 years.

Treatment Agents:	STI571	Home Care:	Patient will self administer the STI-571 at home.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if taking imatinib mesylate (Gleevec®) for 5 years can help to prevent the disease from possibly coming back in patients who have had surgery to remove a GIST.

Study Objectives / Outcomes

Primary objective

To determine recurrence-free survival following the complete resection of significant risk

primary Gastrointestinal stromal tumor(GIST )in patients who are treated with adjuvant
imatinib for 5 years.

Secondary objectives

To determine overall survival.
To assess the safety and tolerability of 5 years of adjuvant imatinib therapy.

Exploratory objectives
To explore the effect of chronic exposure to imatinib on pharmacokinetics through trough level at

steady state for those patients in which data is available.

To explore any relationship between KIT (CD117) and Platelet- derived growth factors (PDGFR) mutation

status of primary tumor and recurrent tumors and related outcome.

To explore pharmacogenomics of tumor tissue to advance our understanding of patient

characteristics and optimize our use of imatinib mesylate in GIST.

Explore quality of life assessment tool Functional Assessment of Cancer

Therapy- General (FACT-G) in adjuvant GIST.

Study Status Information



Study Activation / Registration Date:	09/10/2009

IRB Review and Approval Date:	09/10/2009

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	133

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients greater than or equal to 18 years of age.

2) Patient must have a histological diagnosis of primary GIST.

3) The tumor must express KIT (CD117) protein by immunohistochemistry performed by central pathology.

4) Patient must be at significant risk of tumor recurrence as defined by either: Primary GIST (any site): greater than or equal to 2 cm and a mitotic rate of greater than or equal to 5/50 HPF's , Non-gastric primary GIST: greater than or equal to 5 cm

5) Patient must have undergone complete gross resection of a primary GIST within 12 weeks prior to first dose of imatinib study drug. The inclusion of positive margins( R1 )resections will be reviewed on a case by case basis by the Study Management Committee.

6) Patient must have no evidence of metastatic GIST on either 1) a post-operative CT of the abdomen and pelvis with intravenous and oral contrast or 2) MRI of the abdomen and pelvis with intravenous contrast. CT or MRI must be performed within 8 weeks prior to first dose of imatinib study drug.

7) Performance status 0 or 1 Eastern Cooperative Oncology Group (ECOG)

8) Patient must have the following post-operative laboratory values confirmed within 14 days prior to first dose of imatinib study drug: total bilirubin < 1.5 x ULN NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN , creatinine < 1.5 x ULN, Absolute Neutrophil count(ANC) > 1.5 x 10^9/L , platelets > 100 x 10^9/L

9) If patient is a cancer survivor, ALL of the following criteria apply: Patient has undergone potentially curative therapy for all prior malignancies. No evidence of any prior malignancies for at least 3 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). Pt is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

10) Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 7 days following discontinuation of study drug.

11) Written, voluntary informed consent.

Exclusion Criteria:

1) Patient has metastatic GIST to the peritoneum, liver, lymph node, or other sites or recurrent GIST.

2) Prior treatment for GIST with the exception of prior treatment with adjuvant imatinib lasting less than or equal to 8 weeks following gross surgical resection.

3) Patient has received any other investigational agents within 28 days of first day of study drug dosing.

4) Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)

5) Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risk or compromise compliance with the protocol (i.e., uncontrolled diabetes, chronic renal disease, chronic liver disease, or active uncontrolled infection).

6) Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.

7) Patient receiving concurrent treatment with warfarin (acceptable alternative: lowmolecular weight heparin).

8) Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Links

Registration Number: NCT00867113
Study Information on Clinical Trials Registry (clinicaltrials.gov)