Overview

TAS-102 in Extrapulmonary Neuroendocrine Carcinoma

Status:
Recruiting
Trial end date:
2023-08-15
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to test the safety and efficacy of drug, TAS-102 (trifluridine/tipiracil), in patients with extrapulmonary (outside the lung) high-grade neuroendocrine cancer. TAS-102 demonstrated improved survival and tolerability in patients with colorectal cancer and is currently approved by the FDA and marketed under the brand name Lonsurf for the treatment of patients with metastatic colorectal cancer (mCRC). Recently, a study evaluating TAS-102 showed a case of complete remission of high-grade NEC. Given the safety profile of TAS-102 and the remarkable single agent activity in a disease with otherwise dismal outcomes, we hope that TAS-102 may show tolerability and efficacy in neuro-endocrine cancer and propose further exploration in patients with extrapulmonary (outside the lung) high-grade neuroendocrine cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baylor Research Institute
Collaborator:
Taiho Oncology, Inc.
Treatments:
Trifluridine
Criteria
Inclusion Criteria:

- Pathologic confirmation of high grade NEC using WHO criteria as determined by
Ki67>20%, poorly differentiated (G3) characteristics, or >20 mitotic figures/10
high-power fields.

- Unknown primary may be included. Suspected extrapulmonary patients with known lung
primary will be excluded.

- Prior treatment with a platinum containing regimen

- RECIST 1.1 measurable disease

- Evidence of stage IV, metastatic disease

- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

- Serum albumin ≥2.5 gm/dL.

- Expected survival ≥3 months.

- Adequate hematologic function as defined by: a) Absolute neutrophil count (ANC)
>1500/mm3; b) Platelets ≥75,000/mm3; c) Hemoglobin >8 g/dL (in the absence of red
blood transfusion).

- Adequate liver function, as defined by: a) Serum total bilirubin ≤2.5 x ULN mg/dL. b)
ALT (SGPT) and AST (SGOT) ≤5 x upper limit of normal (ULN).

- Adequate renal function, as defined by serum creatinine ≤2.0 x ULN, or creatinine
clearance ≥30 mL/min

- Females of child bearing potential must agree to use contraception to avoid pregnancy
throughout the study.

Exclusion Criteria:

- Women who are pregnant or breastfeeding.

- Evidence of low-grade or well-differentiated features as determined by the
investigator.

- Functional neuroendocrine tumors are excluded.

- Known pulmonary primary or small cell lung cancer will be excluded.

- Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or
significant ventricular arrhythmias within the last six months.

- Active infection or antibiotics within 48 hours prior to study enrollment, including
unexplained fever (temp > 38°C).

- Other severe and/or uncontrolled medical conditions or other conditions that could
affect their participation such as: a) Severe impaired lung functions as defined by
spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation
that is 88% or less at rest on room air, b) Uncontrolled diabetes,c) Liver disease
such as cirrhosis or severe hepatic impairment, d) Presence of a condition or
abnormality that in the opinion of the Investigator would compromise the safety of the
patient or the integrity of the study.

- Taking other investigational or anti-cancer treatments while participating in this
study. Concurrent radiotherapy is allowed provided to non-target lesions. If target
lesions have received radiation therapy, progression must have been demonstrated prior
to enrollment.

- Prior or concurrent malignancy, except for the following: a) Adequately treated basal
cell or squamous cell skin cancer; b) Cervical carcinoma in situ; c) Adequately
treated Stage I or II cancer from which the subject is currently in complete
remission; d) Or any other cancer from which the subject has been disease-free for 3
years.