Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen by Tanios Bekaii-Saab

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Academic and Community Cancer Research United

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well lower-dose compared to standard dose regorafenib works in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body and does not respond to treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective in treating patients with colorectal cancer. Clobetasol propionate is a steroid cream that is commonly used to treat a variety of skin conditions and may help prevent hand-foot skin reactions in patients receiving regorafenib.

Research Team

Tanios Bekaii-Saab

Principal Investigator

Academic and Community Cancer Research United

Eligibility Criteria

Inclusion Criteria

Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) (obtained =< 7 days prior to randomization)

Serum creatinine =< 1.5 x ULN (obtained =< 7 days prior to randomization)

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria

You have a heart condition that needs medication to control irregular heartbeats, except for pace makers, beta blockers, or digoxin which are allowed.

You have a history of substance abuse, medical, psychological, or social conditions that may affect your ability to participate in the study or make it difficult to interpret the study results.

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Treatment Details

Interventions

• Regorafenib (Kinase Inhibitor)

Participant Groups

Group I: Arm B2 (standard dose regorafenib, reactive clobetasol) Experimental Treatment 4 Interventions

Patients receive standard dose regorafenib PO as in Arm B1 and reactive clobetasol propionate as in Arm A2.

Group II: Arm B1 (standard dose regorafenib, pre-emptive clobetasol) Experimental Treatment 4 Interventions

Patients receive standard dose regorafenib PO QD on days 1-21 and pre-emptive clobetasol propionate as in Arm A1.

Group III: Arm A2 (lower-dose regorafenib, reactive clobetasol) Experimental Treatment 4 Interventions

Patients receive lower-dose regorafenib PO as in Arm A1 and reactive clobetasol propionate given topically BID beginning on day 1 per physician discretion upon occurrence of PPES grade \>= 1.

Group IV: Arm A1 (lower-dose regorafenib, pre-emptive clobetasol) Experimental Treatment 4 Interventions

Patients receive lower-dose regorafenib PO QD on days 1-21 and pre-emptive clobetasol propionate given topically BID for 12 weeks, beginning on day 1 of regorafenib.

Who Is Running the Clinical Trial?

Academic and Community Cancer Research United

Lead Sponsor

Trials

54

Recruited

4,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School