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Second-line FOLFOX With or Without Regorafenib in mCRC Patients Failed to First-line Irinotecan Plus Fluoropyrimidines

NCT01786538 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-03-13

No results posted yet for this study

Summary

Regorafenib has been proved to improved survival in patients with metastatic colorectal cancer who have been failed to all of known standard chemotherapy (The CORRECT study). The phase Ib study of regorafenib plus FOLFOX or FOLFIRI was performed and the dose of regorafenib was fixed; 160 mg/day on days 4 to 10 (7 days per cycle when combined with FOLFOX or FOLFIRI). Regorafenib plus FOLFOX as second-line chemotherapy in mCRC patients who progressed after first-line irinotecan-based chemotherapy has not been studied yet, and because there have been unmet needs for the discovery of valid targeted agent combination for the second-line FOLFOX as above reasons, the investigators planned this study of regorafenib plus FOLFOX as second-line chemotherapy in mCRC patients who progressed after first-line irinotecan-based chemotherapy.

Conditions

Interventions

DRUG

Regorafenib/FOLFOX

FOLFOX consisted of oxaliplatin 85 mg/m2 on D1, leucovorin 400 mg/m2 on D1, 5-fluorouracil 400 mg/m2 intravenous bolus on D1 and 5-fluorouracil 1200 mg/m2/day continuous infusion on D1-2 (2400 mg/m2 for 46 hours). Regorafenib will be administered 160 mg/day given orally on D4-10 (7 days per each cycle of FOLFOX). Treatment will be repeated every 2 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal.

DRUG

Placebo/FOLFOX

FOLFOX consisted of oxaliplatin 85 mg/m2 on D1, leucovorin 400 mg/m2 on D1, 5-fluorouracil 400 mg/m2 intravenous bolus on D1 and 5-fluorouracil 1200 mg/m2/day continuous infusion on D1-2 (2400 mg/m2 for 46 hours). Placebo will be administered 160 mg/day given orally on D4-10 (7 days per each cycle of FOLFOX). Treatment will be repeated every 2 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-05-31
Completion
2017-05-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01786538 on ClinicalTrials.gov