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Gastrointestinal Stromal TumorPhase 2NCT00112632

Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

A Phase 2 study testing imatinib mesylate, conventional surgery and neoadjuvant therapy in people with Gastrointestinal Stromal Tumor, run by Technical University of Munich at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor
What is being tested?
imatinib mesylate, conventional surgery and neoadjuvant therapy
Type of treatment
Surgery or procedure
How many people
40 participants
Where
9 sitesin 2 countries
Study dates
Feb 2005to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastrointestinal stromal tumor
  • Locally advanced disease
  • Potentially resectable disease*
  • No tumor that can be completely resected (R0) with sufficient margins NOTE: *Multivisceral resection may be necessary
  • Tumor must stain positive for c-Kit (CD117) or platelet-derived growth factor receptor-alpha (PDGFRA) by immunohistochemistry
  • 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

Hematopoietic

  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3

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:

Biologic therapy

  • No concurrent anticancer biologic agents

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent systemic corticosteroid therapy unless approved by the study sponsor

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to ≥ 25% of bone marrow

Surgery

  • More than 2 weeks since prior major surgery except tumor biopsy

Other

  • More than 4 weeks since prior investigational drugs unless disease is rapidly progressing
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent warfarin for therapeutic anticoagulation
  • Concurrent low molecular weight heparin (e.g., enoxaparin sodium) or heparin for therapeutic anticoagulation allowed
  • Concurrent mini-dose warfarin (e.g.,1 mg/day) for prophylaxis of central venous catheter thrombosis allowed

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Germany8 sites
  • Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

    Berlin, D-13122

  • Universitaetsklinikum Bonn

    Bonn, D-53105

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

Other trials in Germany

Austria1 site
  • Allgemeines Krankenhaus - Universitatskliniken

    Vienna, A-1090

Other trials in Austria

About this study

Official title: Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-alpha

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.

Read the detailed description

OBJECTIVES:

Primary

  • Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate.
  • Determine histological response in patients treated with this drug.

Secondary

  • Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug.
  • Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection.

After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Being tested
imatinib mesylate, conventional surgery, neoadjuvant therapy
Keywords
gastrointestinal stromal tumor
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall tumor response (complete response, partial response, stable disease, and progression of disease)

Secondary outcomes (2)
  1. Time to progression of disease

  2. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2005 (estimated)
  2. Study startFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112632
Sponsor's protocol ID
CDR0000430499
Other IDs
KRDI-TUM-GIST-CST1571-BDE43, EU-20507
Status last verified
Mar 2012
First submitted
2 Jun 2005
Last updated
8 Mar 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate, conventional surgery and neoadjuvant therapy in people with Gastrointestinal Stromal Tumor, run by Technical University of Munich at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall tumor response (complete response, partial response, stable disease, and progression of disease). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.

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