Status:
ACTIVE_NOT_RECRUITING
TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Colorectal Carcinoma
Recurrent Colon Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 t...
Detailed Description
PRIMARY OBJECTIVE: I. Overall response rate (ORR). SECONDARY OBJECTIVES: I. Progression free survival (PFS). II. Overall survival (OS). III. Disease control rate (DCR). IV. Duration of response. V....
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 27 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04294264
Start Date
February 12 2019
End Date
March 27 2026
Last Update
November 18 2024
Active Locations (6)
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1
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
2
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
3
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
4
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740