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Home > "C" Clinical Trials Conditions > Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor  Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
For Condition: gastrointestinal stromal tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group,Eastern Cooperative Oncology Group,National Cancer Institute of Canada,EORTC Soft Tissue and Bone Sarcoma Cooperative Group,Italian Sarcoma Group,Scandinavian Sarcoma Group,Australian GI Study Participants,Cancer and Leukemia Group B
Synopsis: RATIONALE: STI571 may interfere with the growth of tumor cells and may be an effective treatment for cancer. It is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of STI571 in treating patients who have metastatic or unresectable gastrointestinal stromal tumor.
Details: OBJECTIVES: I. Compare the overall and progression-free survival of patients with CD117- expressing metastatic or unresectable gastrointestinal stromal tumor treated with two different doses of STI571. II. Compare the confirmed, unconfirmed, complete, and partial response rates in patients treated with these regimens. III. Compare the toxic effects of these regimens in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to Zubrod performance status (0-2 vs 3) and measurable disease (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral STI571 once daily. Arm II: Patients receive oral STI571 twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients in arm I with progressive disease may cross over to arm II and receive treatment in the absence of further disease progression. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed gastrointestinal stromal tumor; Distantly metastatic or unresectable disease; Visceral or intra-abdominal primary disease; Immunohistochemical documentation of CD117 expression - No known brain metastasis --Prior/Concurrent Therapy-- - Biologic therapy: At least 28 days since prior biologic therapy and recovered; No concurrent anti-cancer biologic therapy - Chemotherapy: At least 28 days since prior chemotherapy and recovered; No concurrent chemotherapy - Endocrine therapy: Recovered from prior endocrine therapy - Radiotherapy: Recovered from prior radiotherapy; No concurrent radiotherapy - Surgery: At least 14 days since prior major surgery and recovered - Other: At least 28 days since prior investigational drug and recovered; No concurrent therapeutic anticoagulation with warfarin; Concurrent mini-dose oral warfarin (1 mg/day) allowed as prophylaxis for central venous catheter thrombosis; Concurrent therapeutic anticoagulation with low-molecular weight heparin (e.g., enoxaparin) or other agents allowed; No other concurrent investigational drugs --Patient Characteristics-- - Age: 15 and over - Performance status: Zubrod 0-3 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL (transfusion allowed) - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present); No uncontrolled chronic liver disease - Renal: Creatinine no greater than 1.5 times ULN; No uncontrolled chronic renal disease - Cardiovascular: No New York Heart Association class III or IV heart disease; No congestive heart failure; No myocardial infarction within the past 2 months - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception during and for up to 3 months after study; No other severe and/or uncontrolled medical disease; No uncontrolled diabetes; No active uncontrolled infection (e.g., HIV); No medical or psychological condition that would preclude study; No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardSchilsky, Study Chair, Cancer and Leukemia Group B
St. James's Hospital
Leeds, England, LS9 7TF
United Kingdom
CHU de la Timone
Marseille, , 13385
France
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, , 20133
Italy
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Wellington Cancer Centre
Wellington, , 6039
New Zealand
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
National Cancer Institute - Bratislava
Bratislava, , 833 10
Slovakia
Velindre Hospital
Cardiff, Wales, CF4 7XL
United Kingdom
Institut Gustave Roussy
Villejuif, , F-94805
France
Lund University Hospital
Lund, , S-22185
Sweden
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Centre Leon Berard
Lyon, , 69373
France
Klinikum Grosshadern
Munich, , D-81377
Germany
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Institut Jules Bordet
Brussels, , 1000
Belgium
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
Hospital General de Asturias
Oviedo, , 33006
Spain
Universitats-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 8006
Australia
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Instituto Valenciano De Oncologia
Valencia, , 46009
Spain
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
United Kingdom
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, , DK-2730
Denmark
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
Mount Vernon Hospital
Northwood, England, HA6 2RN
United Kingdom
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Robert Roessle Klinik
Berlin, , D-13122
Germany
Aarhus Kommunehospital
Aarhus, , DK-8000
Denmark
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
Hospital de la Santa Cruz I Sant Pau
Barcelona, , 08025
Spain
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Additional Information:
Study ID Numbers: CDR0000068422; CLB-80004,INT-S0033
Study Start Date: December 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009906
Other Gastrointestinal Stromal Tumor Studies:
1. Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
2. Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
3. Temozolomide in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors
4. Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
5. Imatinib Mesylate (Gleevec; STI571) in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed by Surgery
Related Studies:
Other gastrointestinal stromal tumor Clinical Trials
Other Clinical Trials
Other Berlin Clinical Trials
Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
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