TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery

NCT03297710 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: MC1614NCI-2017-01676
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill more tumor cells.

Conditions

Rectal Adenocarcinoma; Recurrent Rectal Carcinoma; Stage IV Rectal Cancer AJCC v7; Stage IVA Rectal Cancer AJCC v7; Stage IVB Rectal Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  Defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients.

  Up to 28 days

Other Outcomes (12)

• Best response as evaluated by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria

  Best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started), assessed up to 6 months

• Incidence and severity of adverse events graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Up to 6 months

• Incidence of toxicities graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Up to 6 months

Study Arms (1)

Treatment (TAS-102, radiation therapy)

EXPERIMENTAL

Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 PO BID and undergo radiation therapy in 10 fractions on days 1-5 and 8-12 in the absence of disease progression or unacceptable toxicity.

Other: Quality-of-Life Assessment; Radiation: Radiation Therapy; Drug: Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (TAS-102, radiation therapy)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (TAS-102, radiation therapy)

Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 DRUG

Given PO

Also known as: Lonsurf, TAS-102, Trifluridine/Tipiracil

Treatment (TAS-102, radiation therapy)

Eligibility Criteria

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

You may qualify if:

• Histological or cytological confirmation of locally recurrent or metastatic rectal adenocarcinoma
• Note: Patients with locally recurrent/persistent disease within the pelvis after primary therapy (chemotherapy, surgery, and/or radiotherapy) are eligible
• Note: Patients who have had prior pelvic radiotherapy with a total dose of =\< 54 Gy are eligible
• Note: Patients with or without metastatic disease (excluding untreated central nervous system \[CNS\] metastasis), with primary pelvic disease or pelvic recurrence are eligible
• Note: Patients with pelvic disease that is potentially resectable or unresectable are eligible
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Expected life expectancy \>= 12 weeks
• Obtained =\< 14 days prior to registration: Absolute neutrophil count (ANC) \>= 1500/mm\^3
• Obtained =\< 14 days prior to registration: Platelet count \>= 100,000/mm\^3
• Obtained =\< 14 days prior to registration: Hemoglobin \>= 9.0 g/dL
• Obtained =\< 14 days prior to registration: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (in patients with well-documented Gilbert's syndrome and the total bilirubin is grade 1, then direct bilirubin value must be =\< 1.0 mg/dL)
• Obtained =\< 14 days prior to registration: Aspartate transaminase (AST) =\< 2 x ULN (=\< 5 x ULN for patients with liver involvement)
• Obtained =\< 14 days prior to registration: Alanine aminotransferase (ALT) =\< 2 x ULN (=\< 5 x ULN for patients with liver involvement)
• Obtained =\< 14 days prior to registration: Alkaline phosphatase =\< 3 x ULN

You may not qualify if:

• Primary resectable rectal cancer
• Prior treatment with TAS-102
• Chemotherapy or immunotherapy =\< 28 days prior to registration
• Radiation therapy =\< 28 days prior to registration; Note: patients with prior pelvic radiation therapy \> 54 Gy are ineligible
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• Other concurrent chemotherapy, immunotherapy, or any ancillary antitumor therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
• Untreated CNS or leptomeningeal metastasis
• Note: CNS or leptomeningeal disease must be stable for \>= 3 months prior to registration
• History of seizure disorder
• 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
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Ascites, pleural effusion, or pericardial fluid requiring drainage in the last 4 weeks prior to registration
• Intestinal obstruction, uncontrolled gastrointestinal hemorrhage, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C
• Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy; Radiation; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Joleen Hubbard

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: September 26, 2017
• First Posted: September 29, 2017
• Study Start: December 11, 2017
• Primary Completion: March 16, 2020
• Study Completion: April 30, 2021
• Last Updated: January 5, 2023

Record last verified: 2022-02

Locations

US (2)