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Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer

ABSTRACT: Interventions: On Day 1, 8, 15, CPT-11 100 mg/m2 l-LV 250 mg/m2 administered simultaneously 5-FU 500 mg/m2 administered subsequently ** It takes 28 days for the one course. ** More than two courses are required. Primary outcome(s): Response Rate Study Design: Single arm Non-randomized

DISEASE(S): Meatastatic Colorectal Cancer

PROVIDER: 2616231 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer

Project description:Interventions: It takes 2 weeks for one course and that is to be repeated. Dose schedule for one course CPT-11 150mg/ m2/day Day 1 5-FU 500 mg/m2/day Day 1 l-LV 15 mg/m2/day Day 1 UFT 300 mg/m2/day Day 1-8 morning LV 75 mg/day Day 1-8 morning Primary outcome(s): response rate Study Design: Single arm Non-randomized

| 2616118 | ecrin-mdr-crc

Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer

Project description:Interventions: Group A:mFOLFOX6 Day 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ------------- | 5-FU 400mg/m2 iv Rapid Group B:TS-1/CPT-11 CPT-11 80 mg/m2CPT-11 80 mg/m2 1.5 hours 1.5 hours TS-1 40-60 mg/m2 | | | | Day 1 day 15 day 21 day 35 One course takes 35 days (5 weeks). Primary outcome(s): Response Rate(RECIST) Study Design: Parallel Randomized

| 2616289 | ecrin-mdr-crc

Chemotherapy with Camptothecin-11 (CPT-11), Fluorouracil (5FU), folinic acid and oxaliplatin in patients with metastatic colorectal cancer

Project description:Interventions: CPT-11+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses: CPT-11: 80 mg/m2 in 250 ml normal saline intravenous injection (IV) over 90 minutes Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours 5FU: 450 mg/m2 IV bolus. This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks). Then, it will be followed by Oxaliplatin+ Folinic Acid+ 5FU weekly for 6 weeks on days 1,8,15,22,29 and 36 (followed by 2 weeks rest for a total cycle duration of 8 weeks) at the following doses: Oxaliplatin: 45 mg/m2 IV over a 90 min infusion Folinic acid: 200 mg/m2 in 500 ml normal saline IV over 2 hours 5FU: 450 mg/m2 IV bolus This 8-week cycle will be administered in an identical manner again (i.e. total 16 weeks). The overall duration of the intervention will be 32 weeks in total (4 cycles). Primary outcome(s): Objective Response Rate (ORR). The ORR will be assessed by imaging methods including computed tomography (CT) scan, bone scan, X-ray etc.[At 32 months from study initiation] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

| 2454913 | ecrin-mdr-crc

Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.

Project description:Interventions: CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 3 consecutive weeks every 5 weeks. Primary outcome(s): response rate Study Design: Single arm Non-randomized

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A phase II experience with neoadjuvant irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) for colorectal liver metastases.

Project description:BackgroundChemotherapy may improve survival in patients undergoing resection of colorectal liver metastases (CLM). Neoadjuvant chemotherapy may help identify patients with occult extrahepatic disease (averting unnecessary metastasectomy), and it provides in vivo chemosensitivity data.MethodsA phase II trial was initiated in which patients with resectable CLM received CPT-11, 5-FU and LV for 12 weeks. Metastasectomy was performed unless extrahepatic disease appeared. Postoperatively, patients with stable or responsive disease received the same regimen for 12 weeks. Patients with progressive disease received either second-line chemotherapy or best supportive care. The primary endpoint was disease-free survival (DFS); secondary endpoints included overall survival (OS) and safety.Results35 patients were accrued. During preoperative chemotherapy, 16 patients (46%) had grade 3/4 toxicities. Resection was not possible in 5 patients. One patient died of arrhythmia following surgery, and 1 patient had transient liver failure. During the postoperative treatment phase, 12 patients (55%) had grade 3/4 toxicities. Deep venous thrombosis (DVT) occurred in 11 patients (34%) at various times during treatment. Of those who underwent resection, median DFS was 23.0 mo. and median OS has not been reached. The overall survival from time of diagnosis of liver metastases was 51.6 mo for the entire cohort.ConclusionA short course of chemotherapy prior to hepatic metastasectomy may serve to select candidates best suited for resection and it may also direct postoperative systemic treatment. Given the significant incidence of DVT, alternative systemic neoadjuvant regimens should be investigated, particularly those that avoid the use of a central venous line.Trial registrationClinicalTrials.gov NCT00168155.

| S-EPMC2693527 | biostudies-literature

Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer

Project description:Interventions: CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks. Bevacizumab 7mg/kg is administered with 30-90 min intravenous injection on days 1, 15. Primary outcome(s): Overall response rate Study Design: Single arm Non-randomized

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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 cancer

Project description:Interventions: UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest. CPT-11 150mg/m2/day is given intravenously on day 1 and 15 of each cycle. Cycles are repeated every 4 weeks, until occuring disease progression or severe toxicities. The administration is done on the 1st day and the 15th day of each cycle. Cycles are repeated every 4 weeks, until occuring disease progression or severe toxicities.FOLFIRI consisted of CPT-11 150 mg/m2 IV over 90 minutes, LV 400 mg/m2 IV over 2 hours, and FU 400 mg/m2 IV bolus, followed by FU 2.400mg/m2 IV over a 46-hour infusion, repeated every 2 weeks. Cycles are repeated every 4 weeks, until evidence of disease progression or severe toxicities. UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive day followed by a 7 days rest. CPT-11 and Bevacizumab are given intravenously on day 1 and 15 of each cycle. Bevacizumab is added dilute to 100mL with physiological salt solution and given intravenously over 90 minutes. After the tolerability of the initial administration time is confirmed, the time can be shortened to 60 minutes. After the tolerability of the second administration time is confirmed, the time can be shortened to 90 minutes. After the administration of Bevacizumab, CPT-11 150mg/m2/day is given Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities. The administration is done on the 1st day and the 15th day of each cycle. Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities. Bevacizumab is added dilute to 100mL with physiological salt solution and give Primary outcome(s): Step1 Toxicity Step2 Progression-free survival Study Design: Parallel Randomized

| 2616452 | ecrin-mdr-crc

S-1 and CPT-11 plus ramucirumab (IRIS+Rmab) as second-line chemotherapy for patients with oxaliplatin-refractory metastatic colorectal cancer: A multicenter phase II study in Japan (N-DOCC-F-C-1701)

Project description:Interventions: Treatment by IRIS+Rmab Ramucirumab at a dose of 10mg/kg was administered as a 120-min infusion and irinotecan at a dose of 150mg/m2 by adjustment by UGT1A1 was administered as a 90-min infusion every 3 weeks. The dose of S-1 was determined according to the patient’s body surface area (BSA). Specifically, the drug was administered orally twice daily for 14 consecutive days at a dose that did not exceed 40 mg/m2 based on BSA as follows-BSA<1.25m2, 40 mg; BSA 1.25-1.5 m2, 50mg twice daily; and BSA >1.5 m2, 60 mg by adjustment of Ccr. Premedication with a 5-HT3 antagonist combined with dexamethasone (+/-) an NK-1 antagonist was recommended in patients before the administration of irinotecan. This treatment was administered until disease progression, unacceptable toxicity, withdrawal of consent, or the physician’s decision to terminate treatment. Primary outcome(s): progrssion free survival (PFS) Study Design: Single arm Non-randomized

| 2643378 | ecrin-mdr-crc

Phase I study of Veliparib in combination with Cisplatin and Vinorelbine for patients with advanced triple-negative breast cancer (TNBC) and/or BRCA mutation-associated breast cancer

Project description:PURPOSE: Preclinically, cisplatin is synergistic with vinorelbine and the poly(ADP-ribose) polymerase (PARP) inhibitor veliparib, and has anti-neoplastic activity in TNBC and BRCA mutation-associated breast cancer. This phase I study assessed veliparib with cisplatin and vinorelbine. PATIENTS AND METHODS: A 3+3 dose escalation design evaluated veliparib administered BID for 14 days with cisplatin (75 mg/m2 day 1) and vinorelbine (25 mg/m2 days 1,8) every 21 days, for six to ten cycles, followed by veliparib monotherapy. Pharmacokinetics, measurement of poly(ADP-ribose) in peripheral blood mononuclear cells, and preliminary efficacy were assessed. Immunohistochemistry and gene expression profiling were performed to evaluate potential predictors of response.

2015-09-09 | GSE72795 | GEO

A phase I/II study of combination therapy with S-1/ CPT-11 plus Panitumumab as second line therapy in metastatic colorectal cancer patients with KRAS wild type

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| 2620657 | ecrin-mdr-crc

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