JPRN-UMIN000001617
Completed
Phase 1
A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC) - C-0401
CPT-11/TS-1 study group0 sites30 target enrollmentJanuary 6, 2009
Conditionsadvanced/recurrent colorectal cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- advanced/recurrent colorectal cancer
- Sponsor
- CPT-11/TS-1 study group
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. Serious drug hypersensitivity or a history of drug allergy 2\. Plerral effusion, peritoneal fluid and pericardial fluid 3\.Active infections 4\. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 5\.Intestines tube paralysis, intestinal obstruction and peptic ulcer 6\. interstitial pnumonitis, pulmonary fibrosis 7\.Need to treatment with flucytosine 8\.Active concomitant malignancy 9\.diabetic that cannot be controlled 10\. symptomatic or asymptomatic but treated heart disease 11\. histry of mental disturbances or cerebrovascular attach 12\. under coutinuous steroid therapy 13\. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 14\.Other conditions not suitable for this study
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A Randomized, phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small-cell lung cancer HOT1401/NJCLG1401JPRN-UMIN000013882orth Japan Lung Cancer Study Group and Hokkaido Lung Cancer Clinical Study Group80
Completed
Phase 2
Multicenter Phase II trial of Irinotecan plus S-1 with cetuximab (IRIS/Cet) in patients with EGFR positive and KRAS wild type of advanced/metastatic colorectal canceradvanced/metastatic colorectal cancerJPRN-UMIN000004882PO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)80
Completed
Phase 2
Randomized phase II trial of irinotecan(CPT-11) plus tegafur/uracil with oral leucovorin(UFT/LV) compared with FOLFIRI in patients with unresectable/recurrent colorectal cancerPatients with previously untreated and unresectable/recurrent colorectal cancerJPRN-UMIN000000951Department of Surgery, School of Medicine, Keio University72
Terminated
Phase 2
Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and OligodendrogliomasAstrocytomaGliomaOligodendrogliomaNCT00360828H. Lee Moffitt Cancer Center and Research Institute10
Active, not recruiting
Not Applicable
Phase II study of irinotecan weekly in combination with trastuzumab in patientswith locally advanced or metastatic HER2-positive breast cancer and increased cancer cell copy number of TOP1”EUCTR2012-002347-23-DKDanish Breast Cancer Group (DBCG)