Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Gastrointestinal Stromal Tumor

Treatments

Procedure: Conventional Surgery

Drug: Imatinib Mesylate

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00028002

RTOG-S-0132

RTOG S-0132

ECOG-RTOG-R0132

NCI-2012-02437 (Registry Identifier)

CDR0000069111

U10CA021661 (U.S. NIH Grant/Contract)

RTOG-0132 (Other Identifier)

ACRIN-6665 (Other Identifier)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

I. Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate.

II. Determine the objective response rate of patients treated with this drug. III. Determine the safety of this drug in these patients.

OUTLINE:

Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Histologically confirmed malignant gastrointestinal stromal tumor
- Potentially resectable primary disease
- Potentially resectable recurrent disease
  - Local or intra-abdominal/pelvic metastatic disease
Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
Primary disease must be visceral, intra-abdominal, or pelvic in origin
At least 1 unidimensionally measurable lesion
- At least 5 cm for primary disease
- At least 2 cm for recurrent disease
At least 1 viable core biopsy tumor specimen obtained within 8 weeks before registration
Performance status - Zubrod 0-2
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
ALT/AST no greater than 2.5 times ULN
No uncontrolled chronic liver disease
Creatinine no greater than 1.5 times ULN
No uncontrolled chronic renal disease
No New York Heart Association class III or IV cardiac disease
Must be able to lie still in the PET scanner for approximately 1-2 hours
No uncontrollable hyperglycemia
No medical or psychological condition that would preclude study participation
No severe or uncontrolled medical disease
No active uncontrolled infection
No known or suspected hypersensitivity to any component of the study drug
Any prior malignancy is allowed provided patient remains disease free from that malignancy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 3 months after study participation
At least 28 days since prior biologic therapy
No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
At least 28 days since prior chemotherapy
At least 28 days since prior radiotherapy
See Disease Characteristics
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