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Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer

Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI Versus Placebo With FOLFIRI as Second-Line Therapy in Patients With Metastatic Colorectal Cancer

NCT01298570•UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.

Detailed Description

This randomized (2:1 ratio), multi-center, placebo-controlled, phase II efficacy study is designed to compare progression-free survival (PFS) between regorafenib + FOLFIRI (5-fluorouracil + leucovorin + irinotecan \[ARM A\] versus placebo + FOLFIRI \[ARM B\]) in patients with metastatic colorectal carcinoma (mCRC) previously treated with a FOLFOX (5-fluorouracil + leucovorin + oxaliplatin) regimen. Secondary objectives include objective response (OR) rates, disease control (DC) rates, and overall survival (OS). A pharmacokinetic (PK) evaluation of irinotecan will be conducted in a subset of patients at selected sites. This trial also incorporates a number of exploratory analyses designed to evaluate potential correlations between blood and tissue biomarkers and clinical benefit.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years of age (no upper age limit)
•2. Histological or cytological documentation of adenocarcinoma of the colon or rectum
•3. Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies required
•4. Metastatic disease not amenable to surgical resection with curative intent
•5. Progression during or within 6 months following administration of a standard regimen\[2\] for treatment of metastatic disease that included oxaliplatin with any of the following agents with or without bevacizumab:
•* 5-fluorouracil (F-FU) with or without leucovorin or levoleucovorin
•* Capecitabine
•Note: In patients receiving FOLFOX, oxaliplatin is sometimes discontinued due to toxicity or as part of maintenance therapy strategy. If such patients progress while on 5-FU alone, they are eligible for this trial. As an example, a patient who is begun on FOLFOX or CapeOx (capecitabine with oxaliplatin, with or without bevacizumab), whose oxaliplatin is held for neurotoxicity and who is switched to capecitabine monotherapy or capecitabine with bevacizumab, would be considered to have had one prior therapy.
•OR
•Patients who develop metastatic disease within 9 months of adjuvant FOLFOX for stage II or III colon cancer
+19 more criteria

Exclusion Criteria

•1. Prior treatment with regorafenib
•2. More than 1 prior chemotherapy regimen for mCRC (see section 3.1.5) Previous adjuvant FOLFOX based chemotherapy is allowed. Prior FOLFIRI or single agent irinotecan is prohibited.
•3. Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator
•4. Pregnant or breastfeeding patients. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of FOLFIRI treatment, and a negative result must be documented before start of treatment.
•5. History of Gilbert's syndrome
•6. Known Dihydropyrimidine dehydrogenase (DPD) deficiency
•7. Pernicious anemia or other anemias due to vitamin B12 deficiency (due to potential masking of deficiency with leucovorin)
•8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of Day 1 of treatment with FOLFIRI
•9. Radiotherapy within 4 weeks prior to first dose of FOLFIRI
•10. Active cardiac disease including any of the following:
+24 more criteria

Locations (24)

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Mount Sinai Medical Center-Miami

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Georgia Cancer Specialists

Atlanta, Georgia, United States

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

University of Louisville James Brown Cancer Center

Louisville, Kentucky, United States

North Shore Long Island Jewish Health System

Manhasset, New York, United States

New York University Langone Medical Center

New York, New York, United States

Seby B. Jones Cancer Center

Boone, North Carolina, United States

Key Dates

Start Date

April 7, 2011

Primary Completion Date

November 15, 2016

Completion Date

October 2, 2020

Last Updated

January 6, 2021

Enrollment

181

ACTUAL participants

Conditions

Colorectal Cancer Metastatic

Interventions

Regorafenib (BAY 73-4506)

DRUG

FOLFIRI

DRUG

Placebo

DRUG

FOLFIRI

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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