TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Oxaliplatin; Trifluridine

Criteria

Inclusion Criteria:

• Histologically confirmed stage IV colon cancer (American Joint Committee on Cancer [AJCC] 7th edition) that has progressed after standard therapy that included fluorouracil (5-FU), irinotecan, oxaliplatin, bevacizumab (unless contraindicated) and an anti-EGFR antibody, if RAS wild type. Patients who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate

• Patients who had received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen

• Progression of disease must be documented on the most recent scan

• Presence of measurable disease

• RAS mutation and mismatch repair deficiency (MMR) status must be determined (or tissue availability for testing if not already determined)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Life expectancy of at least 3 months

• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

• Hemoglobin >= 9 g/dL

• Platelets (PLT) >= 75 x 10^9/L

• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x upper limit of normal (ULN)

• Adequate contraception if applicable

• Women who are nursing and discontinue nursing prior to enrollment in the program

• Ability to take oral medication (i.e., no feeding tube)

• Patient able and willing to comply with study procedures as per protocol

• Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures

Exclusion Criteria:

• Patients who have previously received TAS-102

• Grade 2 or higher peripheral neuropathy (functional impairment)

• Symptomatic central nervous system (CNS) metastases requiring treatment

• Other active malignancy within the last 3 years (except for non-melanoma skin cancer or a non-invasive/in situ cancer)

• Pregnancy or breast feeding

• Current therapy with other investigational agents

• Active infection with body temperature >= 38 degree Celsius (C) due to infection

• Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to drug administration)

• Any anticancer therapy within prior 3 weeks of first dose of study drug

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102

• Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior 4 weeks

• Grade 3 or higher hypersensitivity reaction to oxaliplatin, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication

• Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity)