A phase II study of neoadjuvant chemotherapy with bevacizumab plus mFOLFOX6 for resectable synchronous liver metastasis (SLM) from colorectal cancer: The first report of the Miyagi Hepato-Biliary Pancreatic Clinical Oncology Group.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 593-593
Author(s):  
Yu Katayose ◽  
Junichiro Yamauchi ◽  
Masaya Oikawa ◽  
Naoki Sakurai ◽  
Hiroaki Musya ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Liver Metastases ◽  
Phase Ii ◽  
Initial Treatment ◽  
Phase Ii Study ◽  
University Hospital ◽  
R0 Resection ◽  
Liver Resections ◽  
Grade 3

593 Background: The prognosis of synchronous liver metastases (SLM) from colorectal cancer is poor. Therefore, we conducted a phase II study of neoadjuvant chemotherapy for SLM to determine the appropriate initial treatment. Here, we assessed the effectiveness of bevacizumab combined with mFOLFOX6. Methods: Patients with SLM within 10 nodules were enrolled after R0-resection of the primary colorectal cancer, and received 8 courses of mFOLFOX6 with bevacizumab (the first and last courses were mFOLFOX6 only). The primary endpoint was response rate (RR). Results: Between June 2008, and November 2008, 47 patients (pts) were enrolled from 17 centers. The median age was 62 years (range 32-72 yrs). The median number of metastases was 2 nodules. Three pts were excluded from evaluation of RR because they did not receive any scheduled chemotherapy. The RR was 70.5% (2 complete responses and 29 partial responses). 11 pts (25%) showed stable disease and 2 pts (4.5%) had progressive disease. The liver resections rate was 90.9% (40 pts) and the R0-resection rate was 86.3%(38 pts). Adverse events in order of prevalence were sensory neuropathy, neutropenia, hypertension, leucopenia and so on. Grade 3 and 4 AEs occurred in 21 pts with the most common being Neutropenia. There were 3 Grade 4 AEs: renal failure and 2 pts of neutropenia. Grade 3 or 4 AEs are summarized below. There were no grade 5 AEs. Of note, liver resections were safely performed in the three pts with Grade 4 AEs. Conclusions: Neoadjuvant chemotherapy with bevacizumab plus mFOLFOX6 for liver metastases is effective and well tolerated. The benefit of this therapy as the initial treatment of SLMneeds to be evaluated further by comparison with adjuvant therapy. (This trial is on University hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR). UMIN's unique trial number is UMIN000001568.) [Table: see text]

Randomized Multicenter Phase II Study Comparing a Combination of Fluorouracil and Folinic Acid and Alternating Irinotecan and Oxaliplatin With Oxaliplatin and Irinotecan in Fluorouracil-Pretreated Metastatic Colorectal Cancer Patients

2001 ◽  
Vol 19 (22) ◽  
pp. 4195-4201 ◽  
Author(s):  
Yves Bécouarn ◽  
Erick Gamelin ◽  
Bruno Coudert ◽  
Sylvie Négrier ◽  
Jean-Yves Pierga ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Folinic Acid ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Survival Times ◽  
Activity Data ◽  
Randomized Phase Ii ◽  
Grade 3 ◽  
Intent To Treat ◽  
Colorectal Cancer Patients

PURPOSE: To assess antitumor activity and safety of two regimens in advanced colorectal cancer (CRC) patients with proven fluorouracil (5-FU) resistance in a randomized phase II study: 5-FU/folinic acid (FA) combined with alternating irinotecan (also called CPT-11) and oxaliplatin (FC/FO tritherapy), and an oxaliplatin/irinotecan (OC) combination. PATIENTS AND METHODS: Sixty-two patients were treated: arm FC/FO (32 patients) received, every 4 weeks, FA 200 mg/m2 followed by a 400-mg/m2 5-FU bolus injection, then a 600-mg/m2 continuous infusion of 5-FU on days 1 and 2 every 2 weeks administered alternately with irinotecan (180 mg/m2 on day 1) and oxaliplatin (85 mg/m2 on day 15). Arm OC (30 patients) received oxaliplatin 85 mg/m2 and irinotecan 200 mg/m2 every 3 weeks. RESULTS: In an intent-to-treat analysis, two partial responses lasting 10.7 and 16 months were observed with the tritherapy regimen, and seven (median duration, 11 months; range, 10.6 to 11.4 months) were observed with the bitherapy regimen. Median progression-free and overall survival times were 8.2 and 9.8 months, respectively, in the FC/FO arm and 8.5 and 12.3 months, respectively, in the OC arm. Main grade 3/4 toxicities were, respectively, neutropenia, 53% and 47%; febrile neutropenia, 13% and 3%; diarrhea, 19% and 10%; vomiting, 6% and 13%; and neurosensory toxicity, 3% and 3%. No treatment-related deaths occurred. CONCLUSION: The every-3-weeks OC combination is safe and active in advanced 5-FU–resistant CRC patients. The lower activity data seen with the tritherapy regimen may be related to the lower dose intensities of irinotecan and oxaliplatin in this schedule.

A phase II study of neoadjuvant irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) for resectable liver metastases from colorectal cancer

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 3662-3662 ◽  
Author(s):  
O. F. Bathe ◽  
S. Ernst ◽  
F. Sutherland ◽  
E. Dixon ◽  
J. Koppel ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Phase Ii ◽  
Phase Ii Study

Phase I/II study of irinotecan, UFT, and leucovorin with hepatic arterial infusion in colorectal cancer patients with unresectable liver metastases: Preliminary results

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14549-14549
Author(s):  
T. Yamaguchi ◽  
H. Matsumoto ◽  
K. Takahashi ◽  
M. Yasutome ◽  
T. Mori
Keyword(s):  
Colorectal Cancer ◽  
Phase I ◽  
Liver Metastases ◽  
Phase Ii ◽  
Phase I Study ◽  
Phase Ii Study ◽  
Hepatic Arterial Infusion ◽  
Arterial Infusion ◽  
Unresectable Liver Metastases ◽  
Colorectal Cancer Patients

14549 Background: To determine the maximum-tolerated dose (MTD) and to evaluate the efficacy and tolerability of combination chemotherapy of irinotecan (CPT-11), UFT and leucovorin (LV) with hepatic arterial infusion (HAI) in colorectal cancer patients with unresectable liver metastases. Methods: Patients who had unresectable liver metastases from colorectal cancer were treated concurrently with intravenous CPT-11 on day1 of each 14-day treatment cycle with dose escalation, with orally UFT and LV on day 1–7 of each cycle, and with HAI of 5-FU on day 8–14 of each cycle. The primary objective of this phase I study was to determine the MTD of biweekly intravenous CPT-11 and UFT/LV with HAI of 5-FU. In the phase II study, the primary endpoint was to determine the response rate. Results: In the phase I study, the recommended dose of CPT-11 for phase II study was 140 mg/m2 combined with UFT 300 mg/m2/day, LV 75 mg/body/day and 5-FU 2,000 mg/body/week. Sixteen patients were enrolled onto the phase II study. The six patients treated at the recommended dose during the phase I study also included in the phase II analysis (n = 22). Median number of liver metastases was 12 (range, 3 to 35). Median size of maximum diameter was 6.3 cm (range, 2.0 to 12.0 cm). The most common adverse event was neutropenia. The complete and partial response rate totaled 81.8%. Median survival time has not been reached yet. Eleven patients (50.0%) were ultimately able to undergo liver resection. Conclusions: The combination chemotherapy of CPT-11 and UFT/LV with HAI was safe, well tolerate and effective in current population of the patients with unresectable liver metastases from colorectal cancer. Updated toxicity and response data will be available in the spring of 2007. No significant financial relationships to disclose.

scholarly journals A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection in Patients With Metastatic KRAS Wild‐Type Colorectal Cancer With Liver Metastases Only

2016 ◽  
Vol 21 (3) ◽  
pp. 279 ◽  
Author(s):  
Johanna C. Bendell ◽  
Ahmed Zakari ◽  
James D. Peyton ◽  
Ralph Boccia ◽  
Mark Moskowitz ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Wild Type

Phase II Study of UFT with Leucovorin Plus Hepatic Arterial Infusion with Irinotecan, 5-Fluorouracil and Leucovorin for Non-Resectable Liver Metastases of Colorectal Cancer

Chemotherapy ◽  
2008 ◽  
Vol 55 (2) ◽  
pp. 76-82 ◽  
Author(s):  
Efraim Idelevich ◽  
Franklin Greif ◽  
Eli Mavor ◽  
Rafael Miller ◽  
Hanoch Kashtan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Hepatic Arterial Infusion ◽  
Arterial Infusion

scholarly journals Multicenter Phase II Study of a New Effective S-1 and Irinotecan Combination Schedule in Patients with Unresectable Metastatic or Recurrent Colorectal Cancer

2013 ◽  
Vol 7 ◽  
pp. CMO.S10769 ◽  
Author(s):  
◽  
Yutaka Ogata ◽  
Takaho Tanaka ◽  
Yoshito Akagi ◽  
Nobuya Ishibashi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Median Overall Survival ◽  
Overall Response Rate ◽  
Phase Ii Study ◽  
Progression Free Survival ◽  
Recurrent Colorectal Cancer ◽  
Free Survival ◽  
Multicenter Phase ◽  
Grade 3

Introduction This multicenter phase II study determined the efficacy and safety of new daily oral S-1 and weekly irinotecan (CPT-11) combination schedule in patients with previously untreated advanced or recurrent colorectal cancer. Patients and Methods Patients received first-line chemotherapy comprising S-1 80 mg/m2/day given on days 3 to 7, 10 to 14, and 17 to 21 and 60 mg/m2 CPT-11 administered intravenously on days 1, 8, and 15 of a 28-day cycle. Results A total of 45 eligible patients were enrolled in this study. The overall response rate was 48.9%. Median progression-free survival and median overall survival was 8.1 months and 20.9 months, respectively. The rates of grade 3 or 4 toxicity were as follows: neutropenia, 8.9%; anemia, 4.4%; anorexia, 6.7%; and diarrhea, 6.7%. Conclusions This new S-1 and irinotecan combination schedule appeared to be an effective, well-tolerated, and convenient regimen in patients with advanced colorectal cancer as compared with conventional regimens such as FOLFIRI and IRIS.

Phase II study of fluorouracil, leucovorin, and interferon alfa-2a in metastatic colorectal carcinoma.

1993 ◽  
Vol 11 (9) ◽  
pp. 1737-1745 ◽  
Author(s):  
J L Grem ◽  
E Jordan ◽  
M E Robson ◽  
R A Binder ◽  
J M Hamilton ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Performance Status ◽  
Strong Association ◽  
Eastern Cooperative Oncology Group ◽  
Interferon Alfa ◽  
Hematologic Toxicity ◽  
Ifn Alpha ◽  
Grade 3

PURPOSE To test the activity of a regimen of interferon alfa-2a (IFN alpha-2a) 5 x 10(6) U/m2 subcutaneously (SC) days 1 through 7 combined with leucovorin 500 mg/m2/d intravenously (IV) over 30 minutes and fluorouracil (5-FU) 370 mg/m2/d through IV push 1 hour after leucovorin days 2 through 6 in a phase II study. PATIENTS AND METHODS Forty-six patients with a good performance status (PS) with measurable colorectal cancer and no prior therapy for metastatic disease were entered. Cycles were repeated at 3-week intervals if toxicity had resolved. The 5-FU dose was increased by 15% if toxicity was mild, and decreased by 15% for grade 3 to 4 nonhematologic or grade 4 hematologic toxicity. RESULTS Three complete responses (CRs) and 21 partial responses (PRs) were seen among 44 assessable patients (54%; 95% confidence interval, 39% to 70%). A moderately strong association was noted between PS and response: PS O (n = 26), two CRs and 15 PRs (65%); PS 1 (n = 13), one CR and six PRs (54%); PS 2 (n = 5), zero CRs and zero PRs (0%; two-tailed P = .026). With a median follow-up duration of 18.8 months, the median time to treatment failure (TTF) and survival were 7.8 months and 16.3 months, respectively. Doses were escalated to 425 mg/m2/d 5-FU in 10 patients, but only four tolerated the higher dose. When expressed as the most severe degree of toxicity experienced by each patient across all cycles, grade 3 to 4 toxicity of the following types was observed; mucositis, 37%; diarrhea, 40%; rash, 7%; fatigue, 14%; granulocytopenia, 13%. Dose-limiting toxicity at 370 mg/m2/d 5-FU eventually occurred in 28 patients (61%). Twelve patients (26%) required an IFN alpha-2a dose reduction for constitutional toxicity. CONCLUSION This regimen has promising activity in advanced colorectal cancer, particularly in patients with an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1.

Multicenter Phase II Study to Evaluate a 28-Day Regimen of Oral Fluorouracil Plus Eniluracil in the Treatment of Patients With Previously Untreated Metastatic Colorectal Cancer

2000 ◽  
Vol 18 (15) ◽  
pp. 2894-2901 ◽  
Author(s):  
Sridhar Mani ◽  
Howard Hochster ◽  
Thomas Beck ◽  
Eric M. Chevlen ◽  
Mark A. O’Rourke ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Stable Disease ◽  
Dose Group ◽  
Response Rate ◽  
Phase Ii Study ◽  
Dose Ratio ◽  
Home Based ◽  
Grade 3

PURPOSE: To determine the efficacy of fluorouracil (5-FU) plus eniluracil when administered to patients with previously untreated metastatic colorectal cancer. PATIENTS AND METHODS: In this single-arm phase II study, patients with previously untreated metastatic colorectal cancer received oral eniluracil plus 5-FU (10:1 dose ratio), at 5-FU doses of 1.00 mg/m2 or 1.15 mg/m2 twice daily (every 12 hours) for 28 consecutive days repeated every 5 weeks (one cycle). Treatment continued until there was documented disease progression or unacceptable toxicity. RESULTS: Thirty and 25 patients were enrolled at a starting dose of 1.00 mg/m2 and 1.15 mg/m2, respectively. Fourteen (25%) of 55 patients (95% confidence interval, 15% to 39%) had a partial response, and 20 patients (36%) had stable disease. The median durations of the partial responses and stable disease were 23.9 weeks (range, 12.3 to 52.1+ weeks) and 24.1 weeks (range, 17.1 to 55.6+ weeks), respectively. The median durations of progression-free and overall survival were 22.6 weeks (range, 21.0 to 29.0 weeks) and 59 weeks (range, 4 to 84+ weeks), respectively. The response rate in the 1.15 mg/m2–dose group was similar to the 1.00 mg/m2–dose group (28% v 23%, respectively). Severe (grade 3/4) nonhematologic treatment-related toxicity included diarrhea (nine patients), nausea/vomiting (one patient each), mucositis (two patients), and anorexia (one patient). Severe hematologic toxicities were rare. At the 1.15 mg/m2–dose level, two patients exhibited grade 3 granulocytopenia, and two patients had grade 3 anemia. CONCLUSION: The response rate with oral 5-FU plus eniluracil is comparable with that observed with infusional 5-FU or bolus 5-FU and leucovorin. The toxicity profile of this oral regimen is acceptable for use in an outpatient home-based setting.

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