Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT01282658
Status:
UNKNOWN
Last Update Posted:
2011-02-17
First Post:
2011-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomics Study of CPT-11 as the First-line Chemotherapy for mCRC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2011-01-24', 'studyFirstSubmitQcDate': '2011-01-24', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CPT-11,pharmacogenomics,colorectal cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '16904315', 'type': 'BACKGROUND', 'citation': 'Van Cutsem E, Nordlinger B, Adam R, Kohne CH, Pozzo C, Poston G, Ychou M, Rougier P; European Colorectal Metastases Treatment Group. Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer. 2006 Sep;42(14):2212-21. doi: 10.1016/j.ejca.2006.04.012. Epub 2006 Aug 10.'}, {'type': 'BACKGROUND', 'citation': 'A Report of Cancer Incidence and Mortality from 34 Cancer Registries in China，2006. China Cancer 19:356-65, 2010'}, {'pmid': '17026789', 'type': 'BACKGROUND', 'citation': 'Yoo PS, Lopez-Soler RI, Longo WE, Cha CH. Liver resection for metastatic colorectal cancer in the age of neoadjuvant chemotherapy and bevacizumab. Clin Colorectal Cancer. 2006 Sep;6(3):202-7. doi: 10.3816/CCC.2006.n.036.'}, {'pmid': '11006366', 'type': 'BACKGROUND', 'citation': 'Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000 Sep 28;343(13):905-14. doi: 10.1056/NEJM200009283431302.'}, {'pmid': '10744089', 'type': 'BACKGROUND', 'citation': 'Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000 Mar 25;355(9209):1041-7. doi: 10.1016/s0140-6736(00)02034-1.'}, {'pmid': '19356014', 'type': 'BACKGROUND', 'citation': 'Rhodes KE, Zhang W, Yang D, Press OA, Gordon M, Vallbohmer D, Schultheis AM, Lurje G, Ladner RD, Fazzone W, Iqbal S, Lenz HJ. ABCB1, SLCO1B1 and UGT1A1 gene polymorphisms are associated with toxicity in metastatic colorectal cancer patients treated with first-line irinotecan. Drug Metab Lett. 2007 Jan;1(1):23-30. doi: 10.2174/187231207779814328.'}, {'pmid': '15007088', 'type': 'BACKGROUND', 'citation': 'Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, Karrison T, Janisch L, Ramirez J, Rudin CM, Vokes EE, Ratain MJ. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol. 2004 Apr 15;22(8):1382-8. doi: 10.1200/JCO.2004.07.173. Epub 2004 Mar 8.'}, {'pmid': '17192505', 'type': 'BACKGROUND', 'citation': 'Ramchandani RP, Wang Y, Booth BP, Ibrahim A, Johnson JR, Rahman A, Mehta M, Innocenti F, Ratain MJ, Gobburu JV. The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicity. J Clin Pharmacol. 2007 Jan;47(1):78-86. doi: 10.1177/0091270006295060.'}, {'pmid': '15280927', 'type': 'BACKGROUND', 'citation': 'Marcuello E, Altes A, Menoyo A, Del Rio E, Gomez-Pardo M, Baiget M. UGT1A1 gene variations and irinotecan treatment in patients with metastatic colorectal cancer. Br J Cancer. 2004 Aug 16;91(4):678-82. doi: 10.1038/sj.bjc.6602042.'}, {'pmid': '15709193', 'type': 'BACKGROUND', 'citation': 'Carlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, Rogatko A, Wang H, Blanchard RL. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res. 2005 Feb 1;11(3):1226-36.'}, {'pmid': '12960109', 'type': 'BACKGROUND', 'citation': 'Mathijssen RH, Marsh S, Karlsson MO, Xie R, Baker SD, Verweij J, Sparreboom A, McLeod HL. Irinotecan pathway genotype analysis to predict pharmacokinetics. Clin Cancer Res. 2003 Aug 15;9(9):3246-53.'}, {'pmid': '16257834', 'type': 'BACKGROUND', 'citation': 'Ando Y, Hasegawa Y. Clinical pharmacogenetics of irinotecan (CPT-11). Drug Metab Rev. 2005;37(3):565-74. doi: 10.1080/03602530500316254.'}, {'pmid': '15197779', 'type': 'BACKGROUND', 'citation': 'Paradiso A, Xu J, Mangia A, Chiriatti A, Simone G, Zito A, Montemurro S, Giuliani F, Maiello E, Colucci G. Topoisomerase-I, thymidylate synthase primary tumour expression and clinical efficacy of 5-FU/CPT-11 chemotherapy in advanced colorectal cancer patients. Int J Cancer. 2004 Aug 20;111(2):252-8. doi: 10.1002/ijc.20208.'}, {'pmid': '18509181', 'type': 'BACKGROUND', 'citation': 'Braun MS, Richman SD, Quirke P, Daly C, Adlard JW, Elliott F, Barrett JH, Selby P, Meade AM, Stephens RJ, Parmar MK, Seymour MT. Predictive biomarkers of chemotherapy efficacy in colorectal cancer: results from the UK MRC FOCUS trial. J Clin Oncol. 2008 Jun 1;26(16):2690-8. doi: 10.1200/JCO.2007.15.5580.'}, {'pmid': '16271446', 'type': 'BACKGROUND', 'citation': 'Smith NF, Figg WD, Sparreboom A. Pharmacogenetics of irinotecan metabolism and transport: an update. Toxicol In Vitro. 2006 Mar;20(2):163-75. doi: 10.1016/j.tiv.2005.06.045. Epub 2005 Nov 3.'}, {'pmid': '18347181', 'type': 'BACKGROUND', 'citation': 'Hoskins JM, Marcuello E, Altes A, Marsh S, Maxwell T, Van Booven DJ, Pare L, Culverhouse R, McLeod HL, Baiget M. Irinotecan pharmacogenetics: influence of pharmacodynamic genes. Clin Cancer Res. 2008 Mar 15;14(6):1788-96. doi: 10.1158/1078-0432.CCR-07-1472.'}, {'pmid': '29728798', 'type': 'DERIVED', 'citation': 'Yu Q, Zhang T, Xie C, Qiu H, Liu B, Huang L, Peng P, Feng J, Chen J, Zang A, Yuan X. UGT1A polymorphisms associated with worse outcome in colorectal cancer patients treated with irinotecan-based chemotherapy. Cancer Chemother Pharmacol. 2018 Jul;82(1):87-98. doi: 10.1007/s00280-018-3595-7. Epub 2018 May 4.'}, {'pmid': '27160286', 'type': 'DERIVED', 'citation': 'Li J, Yu Q, Fu S, Xu M, Zhang T, Xie C, Feng J, Chen J, Zang A, Cai Y, Fu Q, Liu S, Zhang M, Hong Q, Huang L, Yuan X. A novel genetic score model of UGT1A1 and TGFB pathway as predictor of severe irinotecan-related diarrhea in metastatic colorectal cancer patients. J Cancer Res Clin Oncol. 2016 Jul;142(7):1621-8. doi: 10.1007/s00432-016-2176-6. Epub 2016 May 9.'}, {'pmid': '24143213', 'type': 'DERIVED', 'citation': 'Huang L, Zhang T, Xie C, Liao X, Yu Q, Feng J, Ma H, Dai J, Li M, Chen J, Zang A, Wang Q, Ge S, Qin K, Cai J, Yuan X. SLCO1B1 and SLC19A1 gene variants and irinotecan-induced rapid response and survival: a prospective multicenter pharmacogenetics study of metastatic colorectal cancer. PLoS One. 2013 Oct 15;8(10):e77223. doi: 10.1371/journal.pone.0077223. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4 key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase, carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this study is to figure out the correlation between the genetic polymorphism and the drug response.', 'detailedDescription': 'collect blood samples,determining genetic contribution to the safety and efficacy of CPT-11.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed colorectal cancer\n2. ≥ 18 years old\n3. Measurable disease, defined as to RECIST criteria\n4. Unresectable metastatic disease OR First recurrence/metastasis after adjuvant therapy and not suitable for operation\n5. FOLFIRI±cetuximab/bevacizumab as the first-line therapy\n6. Without expected course of radiotherapy during the first-line chemotherapy\n7. No previous CPT-11 chemotherapy\n8. ECOG performance status (PS) 0-2\n9. Not pregnant or nursing and Negative pregnancy test\n10. Voluntarily signed the informed consent\n11. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)\n12. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present)\n13. Creatinine clearance \\> 50 mL/min OR serum creatinine ≤ 1.5 times ULN\n\nExclusion Criteria:\n\n1. Brain metastases with obvious symptoms\n2. Severe bone marrow failure and can not be corrected\n3. Chronic diarrhea history\n4. Bowel obstruction without control\n5. Mental illness without control\n6. Clinically significant (i.e., active) cardiovascular disease, including any of the following: Cerebrovascular accidents/ Myocardial infarction/ Unstable angina/ New York Heart Association class II-IV congestive heart failure/ Serious cardiac arrhythmia requiring medication/ Uncontrolled hypertension\n7. Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix\n8. Pelvic radiotherapy for the past 1 year\n9. Known allergy to any of the components of the study medications\n10. Serious, nonhealing wound or ulcer'}, 'identificationModule': {'nctId': 'NCT01282658', 'acronym': 'PSIFL', 'briefTitle': 'Pharmacogenomics Study of CPT-11 as the First-line Chemotherapy for mCRC', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Genetic Variants and the Efficacy or Severe Adverse Reactions of CPT-11 Based Regimens in mCRC', 'orgStudyIdInfo': {'id': 'TJCC-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan x lin, PHD', 'role': 'CONTACT', 'email': 'yxl@medmail.com.cn', 'phone': '0086-02783663342'}, {'name': 'Huang liu, MD', 'role': 'CONTACT', 'email': 'huangliu017@163.com', 'phone': '0086-02783663514'}, {'name': 'Xie C hua, PHD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zhang Tao', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Yuan X Lin, PHD', 'role': 'CONTACT', 'email': 'yxl@medmail.com.cn', 'phone': '0086-02783663342'}, {'name': 'huang liu, MD', 'role': 'CONTACT', 'email': 'huangliu017@163.com', 'phone': '0086-02783663514'}], 'overallOfficials': [{'name': 'Yuan X Lin, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Wuhan University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Yuan Xianglin', 'oldOrganization': 'Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology'}}}}