Trial record 11 of 176 for:    "gastrointestinal stromal tumor"

Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00568750
First received: December 5, 2007
Last updated: December 8, 2013
Last verified: December 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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 Swiss Group for Clinical Cancer Research:

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

Secondary Outcome Measures:
  • Best response as assessed by CT scan/MRI [ Time Frame: according to RECIST criteria ] [ Designated as safety issue: No ]
  • Best response as assessed by fusion PET/CT scan [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
  • Clinical benefit [ Time Frame: Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: calculated from registration until progression or death due to tumor ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: calculated from registration until progression or death ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: calculated from registration until premature trial treatment termination due to any reason ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Overall survival will be calculated from registration until death or last follow-up, up to 5 years. ] [ Designated as safety issue: No ]
  • Adverse drug reactions according to NCI CTCAE v3.0 [ Time Frame: Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v3.0. ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: December 2007
Estimated Study Completion Date: December 2016
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dasatinib
    Dasatinib is given orally 70 mg BID. Dasatinib will be continued until progression, unacceptable toxicity and up to 2 years (26 cycles, each cycle lasting 4 weeks).
    Other Name: Sprycel
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568750

Locations
Finland
Biomedicum Helsinki
Helsinki, Finland, FI-00290
France
Institut Bergonie
Bordeaux, France, 33076
Hopital Edouard Herriot - Lyon
Lyon, France, 69437
Centre Paul Strauss
Strasbourg, France, 67065
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Universitaetsklinikum Essen
Essen, Germany, D-45122
Switzerland
Kantonsspital Baden
Baden, Switzerland, CH-5404
Saint Claraspital AG
Basel, Switzerland, CH-4016
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital Liestal
Liestal, Switzerland, CH-4410
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
City Hospital Triemli
Zurich, Switzerland, CH-8063
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Onkozentrum - Klinik im Park
Zurich, Switzerland, 8002
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Michael Montemurro, MD Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00568750     History of Changes
Other Study ID Numbers: SAKK 56/07, SWS-SAKK-56/07, EU-20789, EUDRACT-2007-002047-24, CDR0000577496
Study First Received: December 5, 2007
Last Updated: December 8, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
gastrointestinal stromal tumor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System 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 August 21, 2014