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Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
This study is currently recruiting participants.
Verified July 2009 by National Cancer Institute (NCI)

First Received on December 5, 2007.   Last Updated on November 3, 2009   History of Changes
Sponsor: Swiss Group for Clinical Cancer Research
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00568750
  Purpose

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: dasatinib
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria at 4 weeks compared to baseline [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best response as assessed by CT scan/MRI according to RECIST criteria [ Designated as safety issue: No ]
  • Best response as assessed by fusion PET/CT scan [ Designated as safety issue: No ]
  • Clinical benefit [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Adverse drug reactions according to NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Mutational status of KIT and PDGFR [ Designated as safety issue: No ]
  • Best response to second-line treatment with another TK-inhibitor [ Designated as safety issue: No ]
  • Time to progression while on second-line treatment with another TK-inhibitor [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: December 2007
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients with gastrointestinal stromal tumors.

Secondary

  • To determine the efficacy and safety of dasatinib in these patients.
  • To correlate the efficacy of dasatinib with KIT and PDGFR mutational status.
  • To correlate the efficacy and safety of dasatinib with dasatinib drug exposure.
  • To determine the efficacy of second-line treatment with another TK-inhibitor.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastrointestinal stromal tumor (GIST)
  • Measurable disease by conventional scans (CT scan or MRI) within 2 weeks prior to study registration
  • Positive PET/CT scan with [^18F]-fluorodeoxyglucose uptake of the target lesions within 2 weeks prior to study registration
  • No signs or history of CNS metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Hemoglobin ≥ 90 g/L (transfusion allowed)
  • Neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • AST and/or ALT ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study therapy
  • No other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
  • No hypocalcemia (i.e., serum calcium ≤ lower limit of normal)
  • No clinically significant cardiovascular disease, including any of the following:

    • Uncontrolled hypertension
    • Congestive heart failure within the past 6 months
    • QTc > 450 msec or major conduction abnormality (unless a cardiac pacemaker is present)
  • No concurrent medical condition (e.g., active autoimmune disease or uncontrolled diabetes) that would impair the ability of the patient to participate in the study (at the judgment of the investigator) or that may increase the risk of toxicity, including any of the following:

    • Pleural or pericardial effusion of any grade
    • Clinically significant coagulation or platelet function disorder (e.g., known von Willebrand's disease)
    • Infection requiring intravenous antibiotics
    • Ongoing significant gastrointestinal bleeding
    • Nausea, vomiting, or malabsorption syndrome that could interfere with ingestion or absorption of oral dasatinib
  • No known hypersensitivity to study drug

PRIOR CONCURRENT THERAPY:

  • No prior therapy for GIST, particularly tyrosine kinase inhibitors at any time
  • More than 30 days since prior participation in a clinical trial
  • At least 7 days since prior and no concurrent potent CYP3A4 inhibitors, including any of the following:

    • Itraconazole, ketoconazole, miconazole, and voriconazole
    • Amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, and ritonavir
    • Ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, imatinib mesylate, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, and telithromycin
  • At least 7 days since prior and no concurrent medications known to prolong the QT interval, including any of the following:

    • Quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, and dofetilide
    • Erythromycin and clarithromycin
    • Chlorpromazine, haloperidol, mesoridazine, thioridazine, and pimozide
    • Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine
  • No concurrent IV bisphosphonates during the first 8 weeks of study treatment
  • No other concurrent experimental drugs or anticancer therapy
  • No concurrent drugs contraindicated for use with dasatinib, according to the dasatinib investigator's brochure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568750

Locations
Finland
Biomedicum Helsinki Recruiting
Helsinki, Finland, FI-00290
Contact: Contact Person     358-947-173-200        
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Contact Person     33-5-56-33-3212        
Hopital Edouard Herriot - Lyon Recruiting
Lyon, France, 69437
Contact: Contact Person     33-4-72-11-7398        
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Contact Person     33-3-88-252-401        
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Contact Person     33-1-42-114-316        
Germany
Universitaetsklinikum Essen Recruiting
Essen, Germany, D-45122
Contact: Contact Person     49-201-723-85-011        
Switzerland
Kantonsspital Baden Recruiting
Baden, Switzerland, CH-5404
Contact: Contact Person     41-56-486-2511        
Saint Claraspital AG Recruiting
Basel, Switzerland, CH-4016
Contact: Contact Person     41-61-685-8325        
Universitaetsspital-Basel Recruiting
Basel, Switzerland, CH-4031
Contact: Contact Person     41-61-265-5714        
Kantonsspital Bruderholz Recruiting
Bruderholz, Switzerland, CH-4101
Contact: Contact Person     41-61-436-3636        
Kantonsspital Graubuenden Recruiting
Chur, Switzerland, CH-7000
Contact: Contact Person     41-21-314-0150        
Hopital Cantonal Universitaire de Geneve Recruiting
Geneva, Switzerland, CH-1211
Contact: Contact Person     41-22-372-7744        
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Contact Person     41-21-314-0150        
Kantonsspital Liestal Recruiting
Liestal, Switzerland, CH-4410
Contact: Contact Person     41-61-925-2715        
Kantonsspital - St. Gallen Recruiting
St. Gallen, Switzerland, CH-9007
Contact: Contact Person     41-71-494-3569        
City Hospital Triemli Recruiting
Zurich, Switzerland, CH-8063
Contact: Contact Person     41-44-466-1273        
UniversitaetsSpital Zuerich Recruiting
Zurich, Switzerland, CH-8091
Contact: Contact Person     41-44-255-2244        
Onkozentrum - Klinik im Park Recruiting
Zurich, Switzerland, 8002
Contact: Contact Person     41-43-344-3333        
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Michael Montemurro, MD Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00568750     History of Changes
Other Study ID Numbers: CDR0000577496, SWS-SAKK-56/07, EU-20789, EUDRACT-2007-002047-24
Study First Received: December 5, 2007
Last Updated: November 3, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
gastrointestinal stromal tumor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012