TAS-OX for Refractory Metastatic Colon Cancer

NCT02848079 | Completed Phase 1 Results DMC

• 1 other identifier: 1605017852
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the safety and effectiveness of oxaliplatin in combination with TAS-102 (TAS-OX) for treatment of patients with metastatic colorectal cancer whose cancer has progressed or recurred after FOLFOX chemotherapy.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall Response Rate was measured by Response Evaluation Criteria In Solid Tumor (RECIST) 1.1 criteria. Tumors were assessed with CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".

  up to 30 days following discontinuation of treatment

Secondary Outcomes (2)

• Progression Free Survival

  from the date of start of treatment to the date of first documented progression or any cause of death assessed up to 12 months.

• Overall Survival

  from the date of start of treatment to the date of any cause of death assessed up to 24 months.

Study Arms (1)

combined TAS-102 and oxaliplatin

EXPERIMENTAL

Combination treatment with TAS-102 and oxaliplatin. Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion. In Part 1 treatments were started at level 1 doses, which were based on prior clinical experience with the medications studied. Dose escalation followed a traditional "3+3" design. The subjects in Part 2 were treated with dose level 3. Oxaliplatin infusion was given on day 1 of each cycle. TAS-102 was taken twice daily on days 1-5 of each cycle.

Drug: combined TAS-102 and TAS-OX

Interventions

combined TAS-102 and TAS-OX DRUG

Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.

combined TAS-102 and oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan and oxaliplatin. 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 (not required for Phase 1 portion of the trial).
• Retrovirus-associated DNA sequences (RAS) mutation and mismatch repair (MMR) status must be determined (or tissue availability for testing if not already determined)
• Age 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy of at least 3 months.
• Patient with adequate organ function:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Hemoglobin ≥ 9 g/dL
• Platelets (PLT) ≥ 75 x 109/L
• Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 5 x Upper limit of normal (ULN)
• Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome).
• Albumin ≥ 2.5 g/dL

You may not qualify if:

• Patients who have previously received TAS-102.
• Grade 2 or higher peripheral neuropathy.
• 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°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.
• Unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).
• Extended field radiation within prior 4 weeks of first dose of study drug or limited field radiation within prior 2 weeks of first dose of study drug.
• Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

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

Results Point of Contact

• Title: Dr. Jeremy Kortmansky
• Organization: Yale University

jeremy.kortmansky@yale.edu

1 (203) 407-8002

Study Officials

• Jeremy S. Kortansky, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 28, 2016
• Study Start: October 31, 2016
• Primary Completion: June 2, 2020
• Study Completion: June 2, 2020
• Last Updated: July 20, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-06

Locations

US (1)