Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Peking University

Status and phase

Completed

Phase 2

Conditions

Gastrointestinal Stromal Tumor

Treatments

Drug: imatinib mesylate

Procedure: conventional surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01267695

WJP-320.6700.09010

Details and patient eligibility

About

Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the chance of relapse after surgery. This phase II trial is studying the effectiveness of perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal stromal tumor.

Full description

Open-label trial in patients with locally advanced GISTs admitted to Department of Surgery, Beijing Cancer Hospital and Institute between April 2010 and May 2013 was carried out prospectively. Patients were planned to be treated with imatinib for duration of 6 months followed by surgical resection. Postoperative imatinib was planned to be administrated for 1.5 years. The primary end point was recurrent free survival (RFS) at 2 years; the secondary end points included objective response rate (ORR), surgical outcomes and drug safety.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Criteria:

DISEASE CHARACTERISTICS:
- Histologically confirmed gastrointestinal stromal tumor
  - Locally advanced disease: tumour size >5 cm and mitotic count >5/HPF; tumour size >10 cm; mitotic count >10/HPF
  - Potentially resectable disease: Multivisceral resection may be necessary to get sufficient margins
- Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
- At least 1 site of measurable disease
- No known brain metastases
PATIENT CHARACTERISTICS:

Age:18 and over Performance status:ECOG 0-3 Life expectancy:Not specified

Platelet count > 100,000/mm3
Absolute neutrophil count > 1,500/mm3 Hepatic
AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
Bilirubin < 1.5 times ULN
No chronic active hepatitis
No cirrhosis
No other chronic liver disease Renal
Creatinine < 1.5 times ULN
No chronic renal disease Cardiovascular
No New York Heart Association class III-IV cardiac disease
No congestive heart failure
No myocardial infarction within the past 6 months Immunology
No active uncontrolled infection
No known HIV positivity Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
Must be medically fit to undergo surgery
No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention
No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention
No uncontrolled diabetes
No other severe or uncontrolled medical disease
No significant history of noncompliance to medical regimens

PRIOR CONCURRENT THERAPY:

No concurrent anticancer biologic agents
More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
No concurrent anticancer chemotherapy
At least 28 days since prior radiotherapy
More than 2 weeks since prior major surgery except tumor biopsy Other
At least 28 days since prior investigational drugs
At least 28 days since prior imatinib mesylate
No concurrent therapeutic doses of warfarin
Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day) prophylaxis is allowed