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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2009-01-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastrointestinal Stromal Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

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.

Group Type EXPERIMENTAL

Conventional Surgery

Intervention Type PROCEDURE

Undergo surgical resection

Imatinib Mesylate

Intervention Type DRUG

Given orally

Interventions

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Conventional Surgery

Undergo surgical resection

Intervention Type PROCEDURE

Imatinib Mesylate

Given orally

Intervention Type DRUG

Other Intervention Names

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CGP 57148 CGP57148B Gleevec Glivec STI 571 STI-571 STI571

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Burton Eisenberg

Role: PRINCIPAL_INVESTIGATOR

Radiation Therapy Oncology Group

Locations

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Radiation Therapy Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Van den Abbeele AD, Gatsonis C, de Vries DJ, Melenevsky Y, Szot-Barnes A, Yap JT, Godwin AK, Rink L, Huang M, Blevins M, Sicks J, Eisenberg B, Siegel BA. ACRIN 6665/RTOG 0132 phase II trial of neoadjuvant imatinib mesylate for operable malignant gastrointestinal stromal tumor: monitoring with 18F-FDG PET and correlation with genotype and GLUT4 expression. J Nucl Med. 2012 Apr;53(4):567-74. doi: 10.2967/jnumed.111.094425. Epub 2012 Mar 1.

Reference Type RESULT

PMID: 22381410 (View on PubMed)

Eisenberg BL, Harris J, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M. Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): early results of RTOG 0132/ACRIN 6665. J Surg Oncol. 2009 Jan 1;99(1):42-7. doi: 10.1002/jso.21160.

Reference Type RESULT

PMID: 18942073 (View on PubMed)

Wang D, Zhang Q, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M, Eisenberg BL. Phase II trial of neoadjuvant/adjuvant imatinib mesylate for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumors: long-term follow-up results of Radiation Therapy Oncology Group 0132. Ann Surg Oncol. 2012 Apr;19(4):1074-80. doi: 10.1245/s10434-011-2190-5. Epub 2011 Dec 28.

Reference Type RESULT

PMID: 22203182 (View on PubMed)