Gastric Cancer in SituPhase 1SOLARNCT03162510
Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers
A Phase 1 study testing Oxaliplatin, Albumin-Bound Paclitaxel /nab-Paclitaxel and S-1 in people with Gastric Cancer in Situ and Pancreatic Cancers, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastric Cancer in Situ, Pancreatic Cancers, Biliary Cancers
- What is being tested?
- Oxaliplatin, Albumin-Bound Paclitaxel /nab-Paclitaxel and S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jun 2018to 31 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taiwan Cooperative Oncology Group, National Health Research Institutes
Taipei
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Gastric Cancer in Situ, Pancreatic Cancers, Biliary Cancers
- Being tested
- Oxaliplatin, Albumin-Bound Paclitaxel /nab-Paclitaxel, S-1, LV
- Keywords
- SOLAR regimen
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Oxalip
Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, every 14 days as a cycle till disease progression
Albumin-Bound Paclitaxel /nab-PaclitaxelDrug
Also called Abraxane
150 mg/m2 IVD 30 min bi-weekly.
S-1Drug
Also called Tegafur,
Tegafur,oral S-1 35mg/m2 twice daily from D1 to D7, every 14 days as a cycle till disease progression.
LVDrug
Also called Lecovorin
LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression
| Study group | Role | What they receive |
|---|---|---|
| SOLAR | Experimental | 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 progression Receives: Drug: Oxaliplatin; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: S-1; Drug: LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Efficacy evaluations: objective tumor response according to RECIST 1.1
Measured: 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.
Measured: Overall survival will be assessed. From date of registration until the date of death, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start26 Jun 2018
- Primary completion7 Jun 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital, National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Tzong Chen, MD PHD, Study chair, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162510
- Sponsor's protocol ID
- TCOG T1216
- Acronym
- SOLAR
- Status last verified
- Jun 2021
- First submitted
- 15 Nov 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38902994
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03162510
- Acronym / sponsor ID
- SOLAR / TCOG T1216
- Conditions
- Gastric Cancer in Situ, Pancreatic Cancers, Biliary Cancers
- Keywords
- SOLAR regimen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Cheng-Kung University Hospital, National Taiwan University Hospital
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOLAR | Experimental | Drug: Oxaliplatin, Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel, Drug: S-1, Drug: LVAlbumin-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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxaliplatinAlso: OxalipOxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, every 14 days as a cycle till disease progression | Drug | SOLAR |
| Albumin-Bound Paclitaxel /nab-PaclitaxelAlso: Abraxane150 mg/m2 IVD 30 min bi-weekly. | Drug | SOLAR |
| S-1Also: Tegafur,Tegafur,oral S-1 35mg/m2 twice daily from D1 to D7, every 14 days as a cycle till disease progression. | Drug | SOLAR |
| LVAlso: LecovorinLV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression | Drug | SOLAR |
Primary outcome
MTD of Oxaliplatin
Time frame: 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.
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.
2 secondary outcomes
tumor response
Time frame: 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
Time frame: Overall survival will be assessed. From date of registration until the date of death, assessed up to 60 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 38902994Tsai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Tzong Chen, MD PHD study chair
National Health Research Institutes, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxaliplatin, Albumin-Bound Paclitaxel /nab-Paclitaxel and S-1 in people with Gastric Cancer in Situ and Pancreatic Cancers, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD of Oxaliplatin (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03162510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.