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The purpose of this study is to determine maximal tolerable dose (MTD) of the combination of docetaxel, oxaliplatin and S1 (DOS) to patients with gastric cancer.
The primary aim of this dose-finding study is to determine the maximum tolerated doses of docetaxel, oxaliplatin and S1 given every second (DOS2w) or third (DOS3w) week as first-line treatment in patients with advanced gastro-esophageal cancer. Secondary end points are to evaluate toxicities according to NCI-CTCAE v. 4, response rate, progression-free survival and overall survival
Primary Outcome Measure:
To determine maximum tolerated dose (MTD) for the the combination regimes (DOS2w) and (DOS3w).
The investigators have planned to examine 4 dose levels of (DOS2w) and 3 dose levels of (DOS3w).
Methods:
This dose-finding study is planned to include a total of 24 patients with advanced gastro-esophageal cancer, adenocarcinoma.
12 patients will be included in (DOS2w) at four at progressively higher dose levels.
Chemotherapy will be repeated day 1 every second week to a maximum of nine courses.
12 patients will be included in (DOS3w) at three progressively higher dose levels.
Chemotherapy will be repeated day 1 every third week to a maximum of six courses.
In both (DOS2w) and (DOS3w) dose-limiting toxicity (DLT) will be evaluated after the first course. In case of DLT among one of the three patients during the first course of treatment additional three patients will be added at the respective dose level. Dose escalation is continues if 0/3 or 1/6 patients experience DLT.
Patients will be evaluated with a ct-scan at baseline and after every three or four cycles to exclude progression and evaluate response. Response is assessed by the investigator according to RECIST version 1.1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOS2W Dose level 1A | Experimental | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. |
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| DOS2W Dose level 2A | Experimental | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. |
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| DOS2W Dose level 3A | Experimental | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. |
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| DOS2W Dose level 4A | Experimental | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. |
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| DOS3W Dose level 1B | Experimental | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks. |
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| DOS3W Dose level 2B | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOS2w Dose level 1A | Drug | Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival | Up to 2 years after first administration of DOS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Pfeiffer, Professor | Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27911128 | Result | Pfeiffer P, Qvortrup C, Krogh M, Schoennemann K, Vestermark LW, Jensen HA, Bjerregaard JK. S-1 in combination with docetaxel and oxaliplatin in patients with advanced gastro-esophageal adenocarcinoma: two parallel phase 1/2a studies. Acta Oncol. 2017 Jan;56(1):46-51. doi: 10.1080/0284186X.2016.1257865. Epub 2016 Dec 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DOS2w 1A | 3 patients Docetaxel mg/m2 day 1: 30 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 30x2 |
| FG001 | DOS2w 2A | 3 patients Docetaxel mg/m2 day 1: 30 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Two parallel phase 1/2a studies with 3+3 design with either DOS given every second week or every third week in Caucasian patients (Table 1). Patients were included into DOS2w and DOS3w in sequence.
In the DOS2w group: Patients received escalating doses of Docetaxel (30-50 mg/m2 on Day 1), fixed doses of O (70 mg/ m2 on Day 1) and S-1 (30-35 mg/m2/day twice daily orally on Days 1-7) every two weeks. In the DOS3w group: Patients received escalating doses of docetaxel (40-60 mg/m2 on Day 1), fixed doses of O (100 mg/ m2 on Day 1) and S-1 (25 mg/m2/day twice daily orally on Days 1-14) every three weeks.
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Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
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| DOS3W Dose level 3B | Experimental | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks. |
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| DOS2w Dose level 2A | Drug | Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
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| DOS2w Dose level 3A | Drug | Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
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| DOS2w Dose level 4A | Drug | Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
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| DOS3w Dose level 1B | Drug | Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
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| DOS3w Dose level 2B | Drug | Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
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| DOS3w Dose level 3B | Drug | Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
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| FG002 | DOS 2w 3A | 6 patients Docetaxel mg/m2 day 1: 40 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2 |
| FG003 | DOS2w 4A | 6 patients Docetaxel mg/m2 day 1: 50 Oxaliplatin mg/m2 day 1: 70 S-1 mg/m2 days 1-7: 35x2 |
| FG004 | DOS3w 1B | 3 patients Docetaxel mg/m2 day 1: 40 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2 |
| FG005 | DOS3w 2B | 8 patients Docetaxel mg/m2 day 1: 50 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2 |
| FG006 | DOS3w 3B | 5 patients Docetaxel mg/m2 day 1: 60 Oxaliplatin mg/m2 day 1: 100 S-1 mg/m2 days 1-7: 25x2 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DOS2W Dose Level 1A | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/m2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
| BG001 | DOS3W Dose Level 1B | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week. DOS3W: Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
| BG002 | DOS2W Dose Level 2A | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS2W: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
| BG003 | DOS2W Dose Level 3A | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS2W: Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
| BG004 | DOS2W Dose Level 4A | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS2W: Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
| BG005 | DOS3W Dose Level 2B | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week. DOS3W: Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
| BG006 | DOS3W Dose Level 3B | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week. DOS3W: Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3rd week. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
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| Primary | Median Overall Survival | Posted | Median | 95% Confidence Interval | Months | Up to 2 years after first administration of DOS |
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18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DOS2w Dose Level 1A | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS2w: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/2) will be given every 2nd week. Dose levels are described in the Participant Flow section. | 3 | 3 | 0 | 3 | 0 | 3 |
| EG001 | DOS2w Dose Level 2A | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS2w: Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. Dose levels are described in the Participant Flow section. | 3 | 3 | 0 | 3 | 0 | 3 |
| EG002 | DOS2w Dose Level 3A | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS2w: Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. Dose levels are described in the Participant Flow section. | 3 | 6 | 2 | 6 | 4 | 6 |
| EG003 | DOS2w Dose Level 4A | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS2w: Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2nd week. Dose levels are described in the Participant Flow section. | 3 | 6 | 2 | 6 | 0 | 6 |
| EG004 | DOS3w Dose Level 1B | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week. DOS3w: Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week. Dose levels are described in the Participant Flow section. | 3 | 3 | 0 | 3 | 0 | 3 |
| EG005 | DOS3w Dose Level 2B | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS3w: Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week. Dose levels are described in the Participant Flow section. | 6 | 8 | 1 | 8 | 1 | 8 |
| EG006 | DOS3w Dose Level 3B | Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week. DOS3w: Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 2nd week. Dose levels are described in the Participant Flow section. | 4 | 5 | 2 | 5 | 3 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea grade 3-4 | Gastrointestinal disorders | Diarrhea | Non-systematic Assessment |
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| Nausea grade 3-4 | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting grade 3-4 | Gastrointestinal disorders | Non-systematic Assessment |
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| Fatigue grade 3-4 | General disorders | Non-systematic Assessment |
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| Neuropathy grade 3-4 | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Per Pfeiffer | Odense University Hospital | +45-26283844 | per.pfeiffer@rsyd.dk |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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