Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2026-02-19 @ 2:12 PM
Study NCT ID:
NCT00569335
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2007-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Combination Therapy With S-1, Irinotecan, and Bevacizumab (SIRB) in Patients With Unresectable or Recurrent Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-01', 'studyFirstSubmitDate': '2007-12-05', 'studyFirstSubmitQcDate': '2007-12-05', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'any time'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival, Response rate, Overall survival, Time to treatment failure, Treatment situation', 'timeFrame': 'every course for first three courses, then every other course'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['S-1, Bevacizumab, Irinotecan'], 'conditions': ['Colorectal, Cancer']}, 'descriptionModule': {'briefSummary': 'Phase II trial of combination therapy with S-1, irinotecan, and bevacizumab (SIRB) in patients with unresectable or recurrent colorectal cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy\n2. Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)\n3. Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.\n\n Preoperative or postoperative irradiation (\\<30 Gy) for rectal cancer is possible\n4. Age \\>20 years\n5. Life expectancy of at least 3 months\n6. ECOG PS of 0 or 1\n7. Adequate function of major organs as defined below:\n\n 1. Hemoglobin \\>9.0 g/dL\n 2. White blood cell count \\>3,000/mm3\n 3. Neutrophil count \\>1,500/mm3\n 4. Platelet count \\>100,000/mm3\n 5. Total bilirubin \\<1.5 mg/dL\n 6. AST and ALT \\<100 U/L (\\<200 U/L in patients with liver metastasis)\n 7. Serum creatinine \\<1.2 mg/dL\n 8. Creatinine clearance estimate by the Cockcroft-Gault method \\>50 mL/min (reduce initial dosage by one step if ≥50 but \\<80 mL/min)\n8. Able to take capsules orally.\n9. No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.\n10. Voluntary written informed consent.\n\nExclusion Criteria:\n\n1. Serious drug hypersensitivity or a history of drug allergy\n2. Active double cancer\n3. Active infections (e.g., patients with pyrexia of 38℃ or higher)\n4. History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.\n5. Uncontrolled hypertension\n6. Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)\n7. Moderate or severe ascites or pleural effusion requiring treatment\n8. Watery diarrhea\n9. Treatment with flucytosine or atazanavir sulfate\n10. Metastasis to the CNS\n11. Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.\n12. Severe mental disorder\n13. Continuous treatment with steroids\n14. Urine dipstick for proteinuria should be \\<2+\n15. Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism\n16. Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks\n17. Long-term daily treatment with aspirin (\\>325 mg/day)\n18. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding\n19. Judged ineligible for participation in the study by the investigator for safety reasons.'}, 'identificationModule': {'nctId': 'NCT00569335', 'briefTitle': 'Phase II Trial of Combination Therapy With S-1, Irinotecan, and Bevacizumab (SIRB) in Patients With Unresectable or Recurrent Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase II Trial of Combination Therapy With S-1, Irinotecan, and Bevacizumab (SIRB) in Patients With Unresectable or Recurrent Colorectal Cancer', 'orgStudyIdInfo': {'id': '01023020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'S-1, Irinotecan, Bevacizumab', 'interventionNames': ['Drug: S-1, Irinotecan, Bevacizumab']}], 'interventions': [{'name': 'S-1, Irinotecan, Bevacizumab', 'type': 'DRUG', 'description': 'S-1 is administered orally on days 1 to 14 of a 21-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA \\<1.25m2), 50 mg (BSA \\>1.25 to \\<1.50 m2), or 60 mg (BSA \\>1.50 m2).\n\nIrinotecan 150 mg/m2 is administered by intravenous infusion on day 1. Bevacizumab 7.5 mg/kg (body weight) is administered by intravenous infusion on day 1.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '104-0045', 'city': 'Tsukiji, Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.66487, 'lon': 139.77004}}], 'overallOfficials': [{'name': 'Yasuhide Yamada', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}