Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 4:21 AM
Study NCT ID:
NCT01308034
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2011-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2016-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2011-03-01', 'studyFirstSubmitQcDate': '2011-03-02', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of DLT occurring at each dose level of sunitinib within 14 weeks after the start of treatment', 'timeFrame': 'within 14 weeks after the start of treatment'}], 'secondaryOutcomes': [{'measure': 'the number of early toxicities (within 14 weeks after the beginning of treatment) and late toxicities (after 14 weeks and until 12 months after the start of treatment) using NCI-CTC v3.0 and RTOG-EORTC', 'timeFrame': 'within 12 months after the start of treatment'}, {'measure': 'response rate at 6 months using MRI (magnetic resonance imaging)', 'timeFrame': '6 months after the start of treatment'}, {'measure': 'progression free survival measured from the date of inclusion to the date of first evidence of progression or date of death of any cause, or to the date of last follow up', 'timeFrame': 'within 12 months after the start of treatment'}, {'measure': 'evolution of neo-angiogenesis during treatment measured by DCE-US', 'timeFrame': 'within 6 weeks after the start of treatment'}, {'measure': 'correlation between clinical response and change of tumor perfusion measured by DCE-US', 'timeFrame': 'within 12 months after the start of treatment'}, {'measure': 'proportion of patients operable after treatment', 'timeFrame': 'at week 6 after the start of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non GIST sarcomas', 'sunitinib', 'radiotherapy', 'dose escalation'], 'conditions': ['Non GIST Sarcomas']}, 'referencesModule': {'references': [{'pmid': '11072162', 'type': 'BACKGROUND', 'citation': 'Alektiar KM, Velasco J, Zelefsky MJ, Woodruff JM, Lewis JJ, Brennan MF. 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Kinetics of vascular normalization by VEGFR2 blockade governs brain tumor response to radiation: role of oxygenation, angiopoietin-1, and matrix metalloproteinases. Cancer Cell. 2004 Dec;6(6):553-63. doi: 10.1016/j.ccr.2004.10.011.'}, {'pmid': '12829126', 'type': 'BACKGROUND', 'citation': 'Gaffney DK, Haslam D, Tsodikov A, Hammond E, Seaman J, Holden J, Lee RJ, Zempolich K, Dodson M. Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) negatively affect overall survival in carcinoma of the cervix treated with radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Jul 15;56(4):922-8. doi: 10.1016/s0360-3016(03)00209-8.'}, {'pmid': '10416597', 'type': 'BACKGROUND', 'citation': 'Gorski DH, Beckett MA, Jaskowiak NT, Calvin DP, Mauceri HJ, Salloum RM, Seetharam S, Koons A, Hari DM, Kufe DW, Weichselbaum RR. Blockage of the vascular endothelial growth factor stress response increases the antitumor effects of ionizing radiation. 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J Clin Oncol. 2009 Jul 1;27(19):3154-60. doi: 10.1200/JCO.2008.20.9890. Epub 2009 May 18."}, {'pmid': '19464823', 'type': 'BACKGROUND', 'citation': 'Crane CH, Eng C, Feig BW, Das P, Skibber JM, Chang GJ, Wolff RA, Krishnan S, Hamilton S, Janjan NA, Maru DM, Ellis LM, Rodriguez-Bigas MA. Phase II trial of neoadjuvant bevacizumab, capecitabine, and radiotherapy for locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):824-30. doi: 10.1016/j.ijrobp.2009.02.037. Epub 2009 May 21.'}, {'pmid': '19887481', 'type': 'BACKGROUND', 'citation': 'Koukourakis MI, Giatromanolaki A, Sheldon H, Buffa FM, Kouklakis G, Ragoussis I, Sivridis E, Harris AL; Tumour and Angiogenesis Research Group. Phase I/II trial of bevacizumab and radiotherapy for locally advanced inoperable colorectal cancer: vasculature-independent radiosensitizing effect of bevacizumab. Clin Cancer Res. 2009 Nov 15;15(22):7069-76. doi: 10.1158/1078-0432.CCR-09-0688. Epub 2009 Nov 3.'}, {'pmid': '16503384', 'type': 'BACKGROUND', 'citation': 'Lordick F, Geinitz H, Theisen J, Sendler A, Sarbia M. Increased risk of ischemic bowel complications during treatment with bevacizumab after pelvic irradiation: report of three cases. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1295-8. doi: 10.1016/j.ijrobp.2005.12.004. Epub 2006 Feb 28.'}, {'pmid': '19636002', 'type': 'BACKGROUND', 'citation': 'Crane CH, Winter K, Regine WF, Safran H, Rich TA, Curran W, Wolff RA, Willett CG. Phase II study of bevacizumab with concurrent capecitabine and radiation followed by maintenance gemcitabine and bevacizumab for locally advanced pancreatic cancer: Radiation Therapy Oncology Group RTOG 0411. J Clin Oncol. 2009 Sep 1;27(25):4096-102. doi: 10.1200/JCO.2009.21.8529. Epub 2009 Jul 27.'}, {'pmid': '18355978', 'type': 'BACKGROUND', 'citation': 'Lai A, Filka E, McGibbon B, Nghiemphu PL, Graham C, Yong WH, Mischel P, Liau LM, Bergsneider M, Pope W, Selch M, Cloughesy T. Phase II pilot study of bevacizumab in combination with temozolomide and regional radiation therapy for up-front treatment of patients with newly diagnosed glioblastoma multiforme: interim analysis of safety and tolerability. Int J Radiat Oncol Biol Phys. 2008 Aug 1;71(5):1372-80. doi: 10.1016/j.ijrobp.2007.11.068. Epub 2008 Mar 20.'}, {'pmid': '19167838', 'type': 'BACKGROUND', 'citation': 'Gutin PH, Iwamoto FM, Beal K, Mohile NA, Karimi S, Hou BL, Lymberis S, Yamada Y, Chang J, Abrey LE. Safety and efficacy of bevacizumab with hypofractionated stereotactic irradiation for recurrent malignant gliomas. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):156-63. doi: 10.1016/j.ijrobp.2008.10.043. Epub 2009 Jan 23.'}, {'pmid': '12873999', 'type': 'BACKGROUND', 'citation': 'Schueneman AJ, Himmelfarb E, Geng L, Tan J, Donnelly E, Mendel D, McMahon G, Hallahan DE. SU11248 maintenance therapy prevents tumor regrowth after fractionated irradiation of murine tumor models. Cancer Res. 2003 Jul 15;63(14):4009-16.'}, {'pmid': '18514780', 'type': 'BACKGROUND', 'citation': 'Cuneo KC, Geng L, Fu A, Orton D, Hallahan DE, Chakravarthy AB. SU11248 (sunitinib) sensitizes pancreatic cancer to the cytotoxic effects of ionizing radiation. Int J Radiat Oncol Biol Phys. 2008 Jul 1;71(3):873-9. doi: 10.1016/j.ijrobp.2008.02.062.'}, {'pmid': '19536893', 'type': 'BACKGROUND', 'citation': 'Kao J, Packer S, Vu HL, Schwartz ME, Sung MW, Stock RG, Lo YC, Huang D, Chen SH, Cesaretti JA. Phase 1 study of concurrent sunitinib and image-guided radiotherapy followed by maintenance sunitinib for patients with oligometastases: acute toxicity and preliminary response. Cancer. 2009 Aug 1;115(15):3571-80. doi: 10.1002/cncr.24412.'}, {'pmid': '7114936', 'type': 'RESULT', 'citation': 'Rosenberg SA, Tepper J, Glatstein E, Costa J, Baker A, Brennan M, DeMoss EV, Seipp C, Sindelar WF, Sugarbaker P, Wesley R. The treatment of soft-tissue sarcomas of the extremities: prospective randomized evaluations of (1) limb-sparing surgery plus radiation therapy compared with amputation and (2) the role of adjuvant chemotherapy. Ann Surg. 1982 Sep;196(3):305-15. doi: 10.1097/00000658-198209000-00009.'}, {'pmid': '8407399', 'type': 'RESULT', 'citation': 'Harrison LB, Franzese F, Gaynor JJ, Brennan MF. Long-term results of a prospective randomized trial of adjuvant brachytherapy in the management of completely resected soft tissue sarcomas of the extremity and superficial trunk. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):259-65. doi: 10.1016/0360-3016(93)90236-o.'}, {'pmid': '9440743', 'type': 'RESULT', 'citation': 'Yang JC, Chang AE, Baker AR, Sindelar WF, Danforth DN, Topalian SL, DeLaney T, Glatstein E, Steinberg SM, Merino MJ, Rosenberg SA. Randomized prospective study of the benefit of adjuvant radiation therapy in the treatment of soft tissue sarcomas of the extremity. J Clin Oncol. 1998 Jan;16(1):197-203. doi: 10.1200/JCO.1998.16.1.197.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery.\n\nThe primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery.\n\nThis study is a multicentre, open-label phase I with dose escalation : 2 dose levels.\n\n3-6 patients will be included at each dose level.3-18 patients will be included in the study.', 'detailedDescription': 'Study design : 2 dose levels\n\nStep 1 : 25 mg once daily Step 2 : 37.5 mg once daily\n\n3-6 patients will be included at each of the sunitinib dose levels, depending on the number of DLTs (dose limiting toxicity) occurring in 14 weeks after start of treatment\n\nDLT is defined as :\n\nany grade 3 or 4 musculoskeletal or cutaneous toxicity within the field of radiation any other toxicity \\> or = 4\n\nSecondary objectives are :\n\n* to evaluate the safety with late toxicities\n* to estimate the response rate at 6 months\n* to estimate the progression free survival\n* to evaluate the proportion of patients with an operable tumour after treatment\n\nExploratory objectives are :\n\n* to study evolution during treatment of neo-angiogenesis measured by dynamic contrast enhanced-ultrasonography (DCE-US)\n* to study the correlation between clinical response and changes of tumor perfusion measured by DCE-US'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients \\> 18 years of age\n2. Histologically or cytologically (in case of recurrence) confirmed connective tissue neoplasm, including any of the following subtypes:\n\n * Liposarcomas\n * Fibrosarcoma, myxofibrosarcoma\n * Undifferentiated pleomorphic sarcoma\n * Leiomyosarcomas\n * Pleomorphic rhabdomyosarcomas only\n * Angiosarcomas\n * Uncertain differentiated tumors: synovial sarcomas, epithelioid sarcomas, alveolar sarcomas, clear cells sarcomas.\n\n or osteosarcoma diagnosis, chondrosarcoma or chordoma.\n3. Locally advanced or locally recurrent inoperable tumor without previous irradiation \\[inoperable status must be assessed by staff including a surgeon specialized in sarcoma\\].\n4. No prior treatment by sunitinib malate\n5. Life expectancy \\> 6 months\n6. ECOG performance status ≤ 2\n7. Blood tests, renal and liver functions in the normal range with, in the 7 days prior to study entry, blood or serum values as follows:\n\n * Absolute neutrophil count ≥ 1.,5 G/L\n * Platelet count ≥ 100 G/L\n * Bilirubin ≤ 1.5 mg/dL\n * PT and INR ≤ 1.5 times upper limit of normal \\[Patients under preventive anticoagulant therapy are allowed to participate\\]\n * AST and ALT ≤ 2.5 times upper limit of normal\n * Creatinine ≤ 150 umol/L\n * Calcium ≤ 12 mg/dL\n * Blood glucose \\< 150 mg/dL\n8. Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study therapy\n9. Ability to swallow oral medications\n10. Mandatory affiliation with a health insurance company\n11. Signed written informed consent.\n\nExclusion Criteria:\n\n1. GIST, Ewing sarcoma or embryonic rhabdomyosarcomas\n2. Radiation field including lung, bowel, or central nervous system\n3. Pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite medication\n4. NCI grade ≥ 3 hemorrhage within the past 4 weeks prior to study drug administration\n5. Significant cardiovascular disease (New York Heart Association (NYHA) \\> grade 2 congestive cardiac failure, myocardial infarction within 6 months prior to inclusion, unstable angina, severe cardiac arrhythmia, severe cerebrovascular accident within 6 months prior to inclusion, history of severe thromboembolism (pulmonary embolism or deep vein thrombosis DVT) within 6 months prior to inclusion (patients with recent history of DVT treated by anticoagulant (except therapeutic warfarin)during at least 6 weeks are eligibles), prolonged QTc interval (QTc \\> 480 msec with Bazett), bradycardia (heart rate \\< 45bpm), electrolytic troubles (hyponatremia\\<120mmol/l, kalemia≥6mmol/l) or uncontrolled hypertension while receiving appropriate medication (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic).\n6. Less than 6 weeks between prior neoplastic treatment by tyrosine kinase inhibitor and inclusion and less than 4 weeks for other neoplastic treatments\n7. Major surgical procedure, open biopsy, or serious non healing wound within 28 days prior to first day of treatment\n8. Concurrent participation in another clinical trial\n9. Other disease or illness within the past 6 months prior to study drug administration, including the following:\n\n * Psychiatric illness or social situation that would preclude study compliance\n * Known human immunodeficiency virus (HIV)- or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection\n10. Known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease\n11. peritoneal carcinosis\n12. number of metastatic sites \\> 2\n13. Restriction of freedom by judicial or administrative decision\n14. Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01308034', 'briefTitle': 'Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy', 'orgStudyIdInfo': {'id': 'RT - SUTENT'}, 'secondaryIdInfos': [{'id': '2010-021551-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'association sunitinib radiotherapy', 'interventionNames': ['Drug: sunitinib']}], 'interventions': [{'name': 'sunitinib', 'type': 'DRUG', 'description': 'All patients will be treated with sunitinib (2 dose levels) once a day (in the morning) for 6 weeks in association with radiotherapy.Radiotherapy will be realised 1-4h after taking sunitinib.\n\nDose level 1 : 25 mg once daily Dose level 2 : 37.5 mg once daily Authorization to include a patient in the upper step will be given only if the deadline of 14 weeks after the start of treatment of last patient included were strictly respected and depending of number of DLT occuring.', 'armGroupLabels': ['association sunitinib radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CHU La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancérologie de l'ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Jean Yves Blay, PR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Léon Bérard, Lyon'}, {'name': 'Marie Pierre Sunyach', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Léon Bérard, Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}