Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX

NCT02425683 | Terminated Phase 2 DMC

• 1 other identifier: 13050
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study, for patients who have Stage IIIC colorectal cancer and who underwent 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) chemotherapy after surgery, will test to see if regorafenib given after the completion of FOLFOX improves treatment, compared to standard of care (SOC), which is no further treatment.

Conditions

Colorectal Neoplasms; Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum

Keywords

Colon Cancer; Rectal Cancer; Colorectal Cancer; Stage IIIC Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Starting Dose of Regorafenib

  To find the starting dose of regorafenib. The first 50 patients will be randomly assigned to receive regorafenib either 120 mg or 160 mg by mouth daily for 1st 21 days of each 28-day cycle for two cycles. Based on safety profile review of adverse events, a final starting dose will be selected for remaining patients assigned to regorafenib.

  1 year

• Number of Patients Completing Full 6 Cycles

  To have at least 75% of enrolled Stage IIIC high-risk colorectal cancer patients in each treatment arm complete the full duration of adjuvant therapy.

  4.5 years

Secondary Outcomes (3)

• Overall survival

  4.5 years

• Number of Adverse Events (AEs)

  4.5 years

• Disease-free survival (DFS)

  4.5 years

Study Arms (2)

Regorafenib

EXPERIMENTAL

Regorafenib 120 or 160 mg by mouth every day for the first 21 days of each 28-day cycle. If the dose is tolerated during the first 2 cycles in the 120 mg group, in Cycle 3 the 120 mg dose will be increased to 160 mg by mouth each day for the first 21 days of each 28-day cycle for 4 more cycles for a total of 6 cycles or 6 months of therapy.

Drug: Regorafenib

Standard of Care (No Treatment)

NO INTERVENTION

No study drug (which is the standard care for Stage IIIC colorectal cancer patients after they've received FOLFOX chemotherapy).

Interventions

Regorafenib DRUG

120 mg or 160 mg by mouth each day for first 21 days of each 28-day cycle, for maximum of 6 cycles

Also known as: Stivarga, BAY 73-4506

Regorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A signed Patient Authorization Form (HIPAA) has been obtained prior to registration
• Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
• Age ≥ 18 years.
• Stage IIIC colorectal cancer (T4a, N2a, M0) or (T3-4a, N2b, M0), or (T4b, N1- N2, M0) (per AJCC 7th ed).
• Must have started adjuvant FOLFOX chemotherapy within 8 weeks of resection for colorectal carcinoma
• CT scan that demonstrates no evidence of disease (NED) after completion of adjuvant therapy Note: This CT scan will also be used for Texture analysis.
• Received FOLFOX within 6 weeks before starting regorafenib
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy of at least 12 weeks (3 months).
• Complete Metabolic Profile (CMP) within normal limits
• Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements:
• Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN
• Alkaline phosphatase limit ≤ 2.5 x ULN
• Lipase ≤ 1.5 x ULN

You may not qualify if:

• Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03\] on repeated measurement) despite optimal medical management.
• Evidence of remaining tumor
• Has local or distant metastasis
• Previous antiangiogenic treatment
• Abnormal hematological, renal, or liver function
• Impaired pulmonary function
• Evidence of ≥ Grade 2 neuropathy
• Active or clinically significant cardiac disease including:
• Congestive heart failure - New York Heart Association (NYHA) \> Class II.
• Active coronary artery disease.
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
• Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
• Evidence or history of bleeding diathesis or coagulopathy.
• Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.

Sponsors & Collaborators

• US Oncology Research: lead
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (1)

24 Sites

Including Dallas, TX, Ocala, FL, Denver, CO, Florida, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Thomas H. Cartwright, MD

  US Oncology Research, McKesson Specialty Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 24, 2015
• Study Start: March 26, 2015
• Primary Completion: September 21, 2017
• Study Completion: September 21, 2017
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

US (1)