Biweekly SOLAR, As First-line C/T In Pts With Gastric, Pancreatic And Biliary Cancers

Study Overview

Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers

The primary purpose of the study is to determine the maximal tolerated dose (MTD) of Oxaliplatin in this phase I study. The secondary objectives are to determine the response rate, progression free survival, overall survival, and safety profiles. Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression.

Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression. In this study (a standard 3 x 3 design), patients will be enrolled in cohort of 3 to receive escalating dose of Oxaliplatin at three dose levels (level I, 60 mg/m2, level II, 75 mg/m2 and level III, 85 mg/m2). Intra-patient dose escalation will not be allowed. If none of the first 3 patients of a cohort experiences a dose limiting toxicity (DLT), then dose escalation will proceed for next cohort of patients. If 1 of 3 patients developed DLT, the cohort will be expanded to 6 patients. If ≤2 patients of the 6 patients experience DLT, then dose escalation will proceed in next study cohort unless 85 mg/m2 have reached. If 2 of the first 3 or ≥3 of 6 patients developed DLT at certain dose level, then dose escalation will be withheld and the prior dose level will be the maximum tolerated dose (MTD). A minimum of 6 evaluable patients will be treated at the MTD dose level with no more than 2 of the 6 patients having DLT at this dose level. The MTD will be considered as the recommended dose for future Phase II studies. The number of patient accrual will range from 12 and 18 (6/dose level) evaluable patients in the dose-finding stage to determine the MTD of Oxaliplatin in this combination regimen. Of patients who experience grade 2 sensory neuropathy after the triplet chemotherapy, Oxaliplatin will be omitted (only nab-paclitaxel plus S-1/LV will be continued) until the recovery of sensory neuropathy to grade 1 or less then Oxaliplatin will be re-instituted. CBC/DC, AST/ALT and BUN/Cr will be determined at baseline and every 2 weeks during study period. Serum level of albumin, bilirubin (T), LDH, Alk-P/GGT, Na/K/Mg/Ca/P and CRP will be determined at baseline and every 4 weeks during the treatment. Radiographic objective tumor response assessment, according to RECIST version 1.1, by CT scan or MRI at baseline, and then every 6 weeks during the study period. Tumor marker, CEA and CA 19-9, will be evaluated at baseline and every 4 weeks during the treatment.

Gastric Cancer in Situ
Pancreatic Cancers
Biliary Cancers

DRUG: Oxaliplatin
DRUG: Albumin-Bound Paclitaxel /nab-Paclitaxel
DRUG: S-1
DRUG: LV

TCOG T1216

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-11-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-04-05
First Submitted that Met QC Criteria 2017-05-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-04-07
First Posted (ACTUAL) 2017-05-22	Results First Posted N/A	Last Verified 2021-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: SOLAR Albumin-Bound Paclitaxel /nab-Paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60~ 85 mg/m2 IVD 2hr at D1, plus Tegafur,oral S-1 35mg/m2 and Folinic acid/LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progressi	DRUG: Oxaliplatin Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, every 14 days as a cycle till disease progression DRUG: Albumin-Bound Paclitaxel /nab-Paclitaxel 150 mg/m2 IVD 30 min bi-weekly. DRUG: S-1 Tegafur,oral S-1 35mg/m2 twice daily from D1 to D7, every 14 days as a cycle till disease progression. DRUG: LV LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SOLAR

Albumin-Bound Paclitaxel /nab-Paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60~ 85 mg/m2 IVD 2hr at D1, plus Tegafur,oral S-1 35mg/m2 and Folinic acid/LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progressi

DRUG: Oxaliplatin

Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, every 14 days as a cycle till disease progression

DRUG: Albumin-Bound Paclitaxel /nab-Paclitaxel

150 mg/m2 IVD 30 min bi-weekly.

DRUG: S-1

Tegafur,oral S-1 35mg/m2 twice daily from D1 to D7, every 14 days as a cycle till disease progression.

DRUG: LV

LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression

Primary Outcome Measures	Measure Description	Time Frame
MTD of Oxaliplatin	Dose-limiting toxicity (DLT),patients will be enrolled in cohort of 3 to receive escalating dose of Oxaliplatin at three dose levels (level I, 60 mg/m2, level II, 75 mg/m2 and level III, 85 mg/m2)or more of defined events.	From date of registration until the date of definition of MTD or first documented progression or date of death from any cause, whichever came first, assessed up to 28weeks.

Secondary Outcome Measures	Measure Description	Time Frame
tumor response	Efficacy evaluations: objective tumor response according to RECIST 1.1	From date of registration until the date of definition of MTD or first documented progression or date of death from any cause, whichever came first, assessed up to 28weeks.
Overall survival	Overall survival: defined as the time from the date of first study treatment to the date of patient death, due to any cause, or to the last date the patient was known to be alive. The primary analysis population for the overall survival will be per-protocol population. The endpoint will also be analyzed in the intent-to-treat population. Kaplan-Meier estimates will be calculated for the overall survival.	Overall survival will be assessed. From date of registration until the date of death, assessed up to 60 months.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Pathologically confirmed adenocarcinoma or carcinoma of the stomach, pancreas and biliary tract with unresectable, recurrence or metastatic disease.
No prior systemic chemotherapy except adjuvant chemotherapy that has completed 6 months prior enrollment.
Palliative RT to bone but not the primary, main tumor site is permitted.
At least one measurable lesion over non-radiated site.
Aged between 20 to 70 years old.
ECOG Performance Status <= 1.
Life expectancy greater than 12 weeks.
Adequate bone marrow function : absolutely neutrophil count >= 1.5 x 109/L or WBC >= 4 x 109/L, hemoglobin >= 9 g/dl, platelet count 100 x 109/L
Adequate liver function : ALT <= 2.5 x ULN and Bilirubin < 1.5 x ULN
Adequate renal function: creatinine < 1.5 x ULN and calculated eGFR> 50 mL/min.

Major surgery within four weeks prior to study enrolment.
Patient with Ampulla vater cancer is excluded.
Patients with suspicious or history of CNS metastasis.
Patients who with active or uncontrolled infections.
Patients who have history of myocardial infarction or unstable angina within 6 months before entry.
Patients with concomitant illness that might be aggravated by chemotherapy.
Patients who are pregnant or with breast feeding.
Other concomitant or previously malignancy within 3 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin, stage 0-I colon or breast treated by surgery only and without evidence of relapsed tumor.
Mental status is not fit for clinical trial
Fertile men and women unless using a reliable and appropriate contraceptive method.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cheng-Kung University Hospital
National Taiwan University Hospital

Investigators

STUDY_CHAIR: Li-Tzong Chen, MD PHD, National Health Research Institutes, Taiwan

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Tsai HJ, Yang SH, Hsiao CF, Kao HF, Su YY, Shan YS, Yen CJ, Du JS, Hsu C, Wu IC, Chen LT. A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study. Oncologist. 2024 Oct 3;29(10):e1396-e1405. doi: 10.1093/oncolo/oyae109.

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