Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-03 @ 5:08 AM
Study NCT ID:
NCT03053167
Status:
UNKNOWN
Last Update Posted:
2017-02-14
First Post:
2017-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan Plus Raltitrexed as Second-line Treatment in Advanced Colorectal Cancer Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'C068874', 'term': 'raltitrexed'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence and Degree of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '12-15 months'}, {'measure': 'Performance Status [WHO-ECOG]', 'timeFrame': '12-15 months'}, {'measure': 'Quality of Life [WHO-QOL]', 'timeFrame': '12-15 months'}], 'primaryOutcomes': [{'measure': 'Progression Free Survival [PFS]', 'timeFrame': '5-6 months'}], 'secondaryOutcomes': [{'measure': 'Overall Survival [OS]', 'timeFrame': '12-15 months'}, {'measure': 'Objective Response Rate [ORR]', 'timeFrame': '12-15 months'}, {'measure': 'Disease Control Rate [DCR]', 'timeFrame': '12-15 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Raltitrexed', 'Irinotecan', 'Second-line Treatment', 'Advanced Colorectal Cancer(ACC)'], 'conditions': ['ColoRectal Cancer']}, 'referencesModule': {'references': [{'pmid': '15865096', 'type': 'RESULT', 'citation': 'Chiara S, Nobile MT, Tomasello L, Acquati M, Taveggia P, Murolo C, Percivale P, Rosso R. Phase II trial of irinotecan and raltitrexed in chemotherapy-naive advanced colorectal cancer. Anticancer Res. 2005 Mar-Apr;25(2B):1391-6.'}, {'pmid': '15083176', 'type': 'RESULT', 'citation': 'Feliu J, Salud A, Escudero P, Lopez-Gomez L, Pericay C, Castanon C, de Tejada MR, Rodriguez-Garcia JM, Martinez MP, Martin MS, Sanchez JJ, Baron MG; Oncopaz Cooperative Group and Associated Hospitals. Irinotecan plus raltitrexed as first-line treatment in advanced colorectal cancer: a phase II study. Br J Cancer. 2004 Apr 19;90(8):1502-7. doi: 10.1038/sj.bjc.6601713.'}, {'pmid': '12187070', 'type': 'RESULT', 'citation': 'Aparicio J, de las Penas R, Vicent JM, Garcera S, Llorca C, Maestu I, Yuste AL, Farres J. Multicenter phase I study of irinotecan plus raltitrexed in patients with 5-fluorouracil-refractory advanced colorectal cancer. Oncology. 2002;63(1):42-7. doi: 10.1159/000065719.'}, {'pmid': '12196368', 'type': 'RESULT', 'citation': 'Carnaghi C, Rimassa L, Garassino I, Zucali PA, Masci G, Fallini M, Morenghi E, Santoro A. Irinotecan and raltitrexed: an active combination in advanced colorectal cancer. Ann Oncol. 2002 Sep;13(9):1424-9. doi: 10.1093/annonc/mdf229.'}, {'pmid': '39223545', 'type': 'DERIVED', 'citation': 'Cheng Y, Teng Z, Zhang Y, Jin B, Zheng Z, Man L, Wang Z, Teng Y, Yu P, Shi J, Luo Y, Wang Y, Zhang J, Zhang H, Liu J, Chen H, Xiao J, Zhao L, Zhang L, Jiang Y, Chen Y, Zhang J, Wang C, Liu S, Qu J, Qu X, Liu Y. Irinotecan plus raltitrexed as second-line treatment in locally advanced or metastatic colorectal cancer patients: a prospective open-label, single-arm, multi-center, phase II study. BMC Cancer. 2024 Sep 2;24(1):1082. doi: 10.1186/s12885-024-12831-4.'}]}, 'descriptionModule': {'briefSummary': 'Irinotecan and raltitrexed are active against advanced colorectal cancer (ACC), act through different mechanisms, and have only partially overlapping toxicity profiles. The purpose of this study is to evaluate efficacy and safety of irinotecan plus raltitrexed as second-line treatment in advanced colorectal cancer patients.', 'detailedDescription': 'The standard initial treatment for patients with advanced colorectal cancer (ACC) not amenable for surgical resection is palliative 5-fluorouracil (5-FU)-based chemotherapy. However, response rates are low and prognosis remains poor, with median survival times about one year. Until recently, second-line therapy options were limited.\n\nIrinotecan is a semisynthetic camptothecin derivate that acts as a DNA-topoisomerase-1 inhibitor,its most frequent toxic effects are diarrhea, neutropenia and cholinergic syndrome. Raltitrexed is a quinazoline folate-based specific thymidylate synthase inhibitor, its clinical activity in this setting is similar to that of modulated 5-FU regimens but with a better toxicity profile (mainly asthenia and increased serum transaminase levels). There seems to be no cross-resistance between 5-FU and raltitrexed. Irinotecan and raltitrexed have different toxicity profiles and modes of action. Both drugs are active as single agents and may be given as a short 3-weekly infusion, thus obviating complex schedules or the need for implantable venous access devices. Preclinical studies have demonstrated a pronounced sequence-dependent synergy between SN-38 (the active metabolite of irinotecan) and raltitrexed. It seems then interesting to explore the feasibility and therapeutic potential of this association.\n\nWith this background, the investigators have performed this study to evaluate efficacy and safety of irinotecan plus raltitrexed as second-line treatment in advanced colorectal cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* life expectancy of at least 3 months;\n* histological and/or cytological confirmation of ACC;\n* disease progression while on first-line palliative oxaliplatin \\& fluoropyrimidine chemotherapy or relapse within 6 months after adjuvant oxaliplatin \\& fluoropyrimidine chemotherapy;\n* wash-out time of 4 weeks after the last chemotherapy infusion or radiotherapy，and observed lesions not in the radiotherapy target；\n* at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；\n* ECOG performance status 0-1；\n* satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥90×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL);\n* For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment\n* written informed consent.\n\nExclusion Criteria:\n\n* prior exposure to irinotecan or raltitrexed;\n* chronic enteropathy on unresolved bowel obstruction;\n* Pregnant or lactated women;\n* previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin;\n* Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment；\n* cerebral metastases or leptomeningeal carcinomatosis;\n* severe or uncompensated concomitant medical conditions.\n* Unsuitable for the study or other chemotherapy determined by investigator.'}, 'identificationModule': {'nctId': 'NCT03053167', 'briefTitle': 'Irinotecan Plus Raltitrexed as Second-line Treatment in Advanced Colorectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Irinotecan Plus Raltitrexed as Second-line Treatment in Advanced Colorectal Cancer Patients: An Open-label, Single-arm, Multicenter Phase II Study', 'orgStudyIdInfo': {'id': 'CLOG1602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irinotecan & Raltitrexed', 'description': 'advanced colorectal cancer patients treated with irinotecan plus raltitrexed as second-line treatment.\n\nIrinotecan:180mg/㎡+NS250ml, ivgtt, 90min, d1\n\nRaltitrexed: 3mg/㎡+NS100ml，ivgtt，15min, d1 Every 3 weeks', 'interventionNames': ['Drug: Irinotecan', 'Drug: Raltitrexed']}], 'interventions': [{'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Campto'], 'description': 'Irinotecan: 180mg/㎡+NS250ml, ivgtt, 90min, d1 Every 3 weeks', 'armGroupLabels': ['Irinotecan & Raltitrexed']}, {'name': 'Raltitrexed', 'type': 'DRUG', 'otherNames': ['Sai wei jian'], 'description': 'Raltitrexed: 3mg/㎡+NS100ml，ivgtt，15min, d1 Every 3 weeks', 'armGroupLabels': ['Irinotecan & Raltitrexed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunpeng Liu, MD., PhD', 'role': 'CONTACT', 'email': 'cmuliuyunpeng@hotmail.com', 'phone': '86-24-83282312'}, {'name': 'Yunpeng Liu, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'YunPeng Liu, PhD', 'role': 'CONTACT', 'email': 'cmuliuyunpeng@hotmail.com', 'phone': '86-24-83282312'}, {'name': 'Zan Teng, PhD', 'role': 'CONTACT', 'email': 'tengzan@163.com', 'phone': '86-024-83282542'}], 'overallOfficials': [{'name': 'YunPeng Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of China Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'Liaoning Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Medical Oncology，The First Hospital of China Medical University', 'investigatorFullName': 'Yunpeng Liu', 'investigatorAffiliation': 'China Medical University, China'}}}}