High-grade Extra Pulmonary Neuroendocrine Cancer Clinical Trial
— TAS-102 NECOfficial title:
An Open-label, Phase II Investigation of TAS-102 in Patients With High Grade, Extrapulmonary Neuroendocrine Carcinoma
| Verified date | January 2020 |
| Source | Baylor Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 14 |
| Est. completion date | August 15, 2023 |
| Est. primary completion date | August 15, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Baylor Scott and White University Medical Center, | Dallas | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Baylor Research Institute | Taiho Oncology, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | To assess clinical activity [ORR = Partial response (PR)+Complete response (CR) ] of TAS-102 in patients with metastatic, extra pulmonary high grade NEC | 24 months | |
| Secondary | Overall Survival (OS) | To assess OS in patients with metastatic extra pulmonary high grade NEC who received TAS-102 In comparison with historical records. | 24 months | |
| Secondary | Progression free survival (PFS) | To assess PFS in patients with metastatic extra pulmonary high grade NEC who received TAS-102 in comparison with historical records | 24 months |