First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus orPhase 1DOSNCT01928524

Chemotherapy for Patients With Cancer of the Stomach

A Phase 1 study testing DOS2w Dose level 1A, DOS2w Dose level 2A and DOS2w Dose level 3A in people with First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or, run by Per Pfeiffer at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
What is being tested?: DOS2w Dose level 1A, DOS2w Dose level 2A and DOS2w Dose level 3A
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteDenmark
Study dates: Sep 2013to 17 Dec 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histological proven adenocarcinoma of the esophagus or the ventricle (ECV), and which cannot be treated curatively.
Age ≥ 18 years.
WHO performance status 0-1.
Neutrophils ≥ 1,5 x 109/L and platelets ≥ 100 x 109/L.
Bilirubin ≤ 1,5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL.
Creatinine-clearance ≥ 60 ml/min.
Planned first day of treatment within 8 days after inclusion in the study.
Signed consent form.

Who cannot join

No previous treatment with chemotherapy, except for (neo)-adjuvant chemotherapy for adenocarcinoma - treatment should have been completed at least 6 months before entrance in this study.
No sensory neuropathy.
No previously treatment with docetaxel, oxaliplatin or S1.
No clinical suspicion of brain metastases.
No cytotoxic treatment or other experimental treatment within 2 weeks of inclusion in the study.
Other serious disease (i.e. heart disease, AMI within 1 year or ongoing infection).

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No pregnant women or women who are lactating. Patients who are not using contraception.
No known DPD-deficiency or known allergy to taxanes or platinum.
No signs of physical or mental illness that would prevent absorption of oral treatment.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Odense University Hospital
Odense, 5000

Other trials in Denmark

About this study

Official title: Phase I Trial With Docetaxel, Oxaliplatin and S1 as First-line Treatment for Patients With Non-resectable Adenocarcinoma of the Esophagus or Gastric

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.

Read the detailed description

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.

Conditions: First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
Being tested: DOS2w Dose level 1A, DOS2w Dose level 2A, DOS2w Dose level 3A, DOS2w Dose level 4A, DOS3w Dose level 1B
Keywords: Gastric cancer, Cancer of the esophagus, Oxaliplatin, Docetaxel, S1
Medical subject headings: Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DOS2w Dose level 1ADrug
Also called DOS2w 1A
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.
DOS2w Dose level 2ADrug
Also called DOS2w 2A
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.
DOS2w Dose level 3ADrug
Also called DOS2w 3A
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.
DOS2w Dose level 4ADrug
Also called DOS2w 4A
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.
DOS3w Dose level 1BDrug
Also called DOS3w 1B
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.
DOS3w Dose level 2BDrug
Also called DOS3w 2B
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.
DOS3w Dose level 3BDrug
Also called DOS3w 3B
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.

Study groups in NCT01928524
Study group	Role	What they receive
DOS2W Dose level 1A	Experimental	Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. Receives: Drug: DOS2w Dose level 1A
DOS2W Dose level 2A	Experimental	Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. Receives: Drug: DOS2w Dose level 2A
DOS2W Dose level 3A	Experimental	Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. Receives: Drug: DOS2w Dose level 3A
DOS2W Dose level 4A	Experimental	Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks. Receives: Drug: DOS2w Dose level 4A
DOS3W Dose level 1B	Experimental	Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks. Receives: Drug: DOS3w Dose level 1B
DOS3W Dose level 2B	Experimental	Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks. Receives: Drug: DOS3w Dose level 2B
DOS3W Dose level 3B	Experimental	Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks. Receives: Drug: DOS3w Dose level 3B

What is being measured

The primary outcome is the main question the study is designed to answer.

Median Overall Survival
Measured: Up to 2 years after first administration of DOS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201317 Dec 2015

First posted26 Aug 2013 (estimated)
Study startSep 2013
Primary completion5 Jun 2015
Study completion17 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus orStudies 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: Non-randomised
Intervention model: Sequential
Model description: 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.
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01928524
Sponsor's protocol ID: KFE 12.17
Acronym: DOS
Status last verified: Jan 2021
First submitted: 21 Aug 2013
Last updated: 16 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27911128

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Trial With Docetaxel, Oxaliplatin and S1 as First-line Treatment for Patients With Non-resectable Adenocarcinoma of the Esophagus or Gastric
ClinicalTrials.gov ID: NCT01928524
Acronym / sponsor ID: DOS / KFE 12.17
Conditions: First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
Keywords: Gastric cancer, Cancer of the esophagus, Oxaliplatin, Docetaxel, S1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Per PfeifferUniversity, hospital or other
Study start: Sep 2013
Primary completion: 5 Jun 2015 (actual)
Study completion: 17 Dec 2015 (actual)
First posted: 26 Aug 2013 (estimated)
Results: Posted 16 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7
Model description: 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.

Arm	Type	Receives
DOS2W Dose level 1A	Experimental	Drug: DOS2w Dose level 1ATreatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
DOS2W Dose level 2A	Experimental	Drug: DOS2w Dose level 2ATreatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
DOS2W Dose level 3A	Experimental	Drug: DOS2w Dose level 3ATreatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
DOS2W Dose level 4A	Experimental	Drug: DOS2w Dose level 4ATreatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
DOS3W Dose level 1B	Experimental	Drug: DOS3w Dose level 1BTreatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
DOS3W Dose level 2B	Experimental	Drug: DOS3w Dose level 2BTreatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
DOS3W Dose level 3B	Experimental	Drug: DOS3w Dose level 3BTreatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Histological proven adenocarcinoma of the esophagus or the ventricle (ECV), and which cannot be treated curatively.
Age ≥ 18 years.
WHO performance status 0-1.
Neutrophils ≥ 1,5 x 109/L and platelets ≥ 100 x 109/L.
Bilirubin ≤ 1,5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL.

Key exclusion criteria (9 listed)

No previous treatment with chemotherapy, except for (neo)-adjuvant chemotherapy for adenocarcinoma - treatment should have been completed at least 6 months before entrance in this study.
No sensory neuropathy.
No previously treatment with docetaxel, oxaliplatin or S1.
No clinical suspicion of brain metastases.
No cytotoxic treatment or other experimental treatment within 2 weeks of inclusion in the study.

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
DOS2w Dose level 1AAlso: DOS2w 1ADocetaxel (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.	Drug	DOS2W Dose level 1A
DOS2w Dose level 2AAlso: DOS2w 2ADocetaxel (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.	Drug	DOS2W Dose level 2A
DOS2w Dose level 3AAlso: DOS2w 3ADocetaxel (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.	Drug	DOS2W Dose level 3A
DOS2w Dose level 4AAlso: DOS2w 4ADocetaxel (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.	Drug	DOS2W Dose level 4A
DOS3w Dose level 1BAlso: DOS3w 1BDocetaxel (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.	Drug	DOS3W Dose level 1B
DOS3w Dose level 2BAlso: DOS3w 2BDocetaxel (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.	Drug	DOS3W Dose level 2B
DOS3w Dose level 3BAlso: DOS3w 3BDocetaxel (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.	Drug	DOS3W Dose level 3B

Primary outcome

Median Overall Survival
Time frame: Up to 2 years after first administration of DOS

Results and safety

Results posted to the registry on 16 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DOS2w 1A	3	3
DOS2w 2A	3	3
DOS 2w 3A	6	6
DOS2w 4A	6	6
DOS3w 1B	3	3
DOS3w 2B	8	8
DOS3w 3B	5	5

Primary outcome: Median Overall Survival

Time frame: Up to 2 years after first administration of DOS. Median (95% Confidence Interval). Unit: Months

Measure	DOS2W 1A n = 3	DOS2W 2A n = 3	DOS2W 3A n = 6	DOS2W 4A n = 6	DOS3W 1B n = 3	DOS3W 2B n = 8	DOS3W 3B n = 5
Value	4.3 (1 to 8)	13.8 (7 to 16)	14.6 (7 to 25)	15.2 (6 to 26)	8.3 (5 to 12)	16.4 (8 to 24)	7.8 (4 to 13)

Adverse events

Time frame: 18 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DOS2w Dose Level 1A	0 of 3 (0%)	0 of 3 (0%)	3 of 3
DOS2w Dose Level 2A	0 of 3 (0%)	0 of 3 (0%)	3 of 3
DOS2w Dose Level 3A	2 of 6 (33.3%)	4 of 6 (66.7%)	3 of 6
DOS2w Dose Level 4A	2 of 6 (33.3%)	0 of 6 (0%)	3 of 6
DOS3w Dose Level 1B	0 of 3 (0%)	0 of 3 (0%)	3 of 3
DOS3w Dose Level 2B	1 of 8 (12.5%)	1 of 8 (12.5%)	6 of 8
DOS3w Dose Level 3B	2 of 5 (40%)	3 of 5 (60%)	4 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27911128Pfeiffer 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.

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.

Per Pfeiffer, Professor study chair

Odense University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 9 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 16 Feb 2021. 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 Denmark. 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?

Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Median Overall Survival (time frame: Up to 2 years after first administration of DOS). 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 NCT01928524, 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 16 Feb 2021.