NCT01928524

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

August 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2015

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

August 21, 2013

Results QC Date

October 29, 2020

Last Update Submit

January 28, 2021

Conditions

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

Keywords

Gastric cancerCancer of the esophagusOxaliplatinDocetaxelS1

Outcome Measures

Primary Outcomes (1)

  • Median Overall Survival

    Up to 2 years after first administration of DOS

Study Arms (7)

DOS2W Dose level 1A

EXPERIMENTAL

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.

Drug: DOS2w Dose level 1A

DOS2W Dose level 2A

EXPERIMENTAL

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.

Drug: DOS2w Dose level 2A

DOS2W Dose level 3A

EXPERIMENTAL

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.

Drug: DOS2w Dose level 3A

DOS2W Dose level 4A

EXPERIMENTAL

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.

Drug: DOS2w Dose level 4A

DOS3W Dose level 1B

EXPERIMENTAL

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.

Drug: DOS3w Dose level 1B

DOS3W Dose level 2B

EXPERIMENTAL

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.

Drug: DOS3w Dose level 2B

DOS3W Dose level 3B

EXPERIMENTAL

Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.

Drug: DOS3w Dose level 3B

Interventions

DOS2w Dose level 1ADRUG

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.

Also known as: DOS2w 1A
DOS2W Dose level 1A
DOS2w Dose level 2ADRUG

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.

Also known as: DOS2w 2A
DOS2W Dose level 2A
DOS2w Dose level 3ADRUG

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.

Also known as: DOS2w 3A
DOS2W Dose level 3A
DOS2w Dose level 4ADRUG

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.

Also known as: DOS2w 4A
DOS2W Dose level 4A
DOS3w Dose level 1BDRUG

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.

Also known as: DOS3w 1B
DOS3W Dose level 1B
DOS3w Dose level 2BDRUG

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.

Also known as: DOS3w 2B
DOS3W Dose level 2B
DOS3w Dose level 3BDRUG

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.

Also known as: DOS3w 3B
DOS3W Dose level 3B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Signed consent form.

You may not qualify if:

  • 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.
  • Other serious disease (i.e. heart disease, AMI within 1 year or ongoing infection).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 27911128RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Results Point of Contact

Title
Per Pfeiffer
Organization
Odense University Hospital
per.pfeiffer@rsyd.dk
+45-26283844

Study Officials

  • Per Pfeiffer, Professor

    Odense University Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 26, 2013

Study Start

September 1, 2013

Primary Completion

June 5, 2015

Study Completion

December 17, 2015

Last Updated

February 16, 2021

Results First Posted

February 16, 2021

Record last verified: 2021-01

Locations

DK(1)