Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers
SOLAR
An Phase I Dose-Escalation Study of Biweekly Abraxane in Combination With Oxaliplatin and Oral S-1/LV (SOLAR Regimen) as First-line Chemotherapy in Patients With Advanced Gastric, Pancreatic and Biliary Cancers
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2018
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
May 22, 2017
CompletedStudy Start
First participant enrolled
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedApril 7, 2022
June 1, 2021
3 years
November 15, 2016
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
tumor response
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 will be assessed. From date of registration until the date of death, assessed up to 60 months.
Study Arms (1)
SOLAR
EXPERIMENTALAlbumin-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 progression
Interventions
Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, every 14 days as a cycle till disease progression
150 mg/m2 IVD 30 min bi-weekly.
Tegafur,oral S-1 35mg/m2 twice daily from D1 to D7, every 14 days as a cycle till disease progression.
LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taiwan Cooperative Oncology Group, National Health Research Institutes
Taipei, Taiwan
Related Publications (1)
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.
PMID: 38902994DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Li-Tzong Chen, MD PHD
National Health Research Institutes, Taiwan
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
November 15, 2016
First Posted
May 22, 2017
Study Start
June 26, 2018
Primary Completion
June 7, 2021
Study Completion
January 31, 2022
Last Updated
April 7, 2022
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share