Chemotherapy for Patients With Cancer of the Stomach (DOS)

January 28, 2021 updated by: Per Pfeiffer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. No sensory neuropathy.
  3. No previously treatment with docetaxel, oxaliplatin or S1.
  4. No clinical suspicion of brain metastases.
  5. No cytotoxic treatment or other experimental treatment within 2 weeks of inclusion in the study.
  6. Other serious disease (i.e. heart disease, AMI within 1 year or ongoing infection).
  7. No pregnant women or women who are lactating. Patients who are not using contraception.
  8. No known DPD-deficiency or known allergy to taxanes or platinum.
  9. No signs of physical or mental illness that would prevent absorption of oral treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DOS2W Dose level 1A
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Drug: DOS2w Dose level 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.
Other Names:
  • DOS2w 1A
Experimental: DOS2W Dose level 2A
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Drug: DOS2w Dose level 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.
Other Names:
  • DOS2w 2A
Experimental: DOS2W Dose level 3A
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Drug: DOS2w Dose level 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.
Other Names:
  • DOS2w 3A
Experimental: DOS2W Dose level 4A
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Drug: DOS2w Dose level 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.
Other Names:
  • DOS2w 4A
Experimental: DOS3W Dose level 1B
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
Drug: DOS3w Dose level 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.
Other Names:
  • DOS3w 1B
Experimental: DOS3W Dose level 2B
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
Drug: DOS3w Dose level 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.
Other Names:
  • DOS3w 2B
Experimental: DOS3W Dose level 3B
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
Drug: DOS3w Dose level 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.
Other Names:
  • DOS3w 3B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median Overall Survival
Time Frame: Up to 2 years after first administration of DOS
Up to 2 years after first administration of DOS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Pfeiffer

Investigators

  • Study Chair: Per Pfeiffer, Professor, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 5, 2015

Study Completion (Actual)

December 17, 2015

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 26, 2013

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFE 12.17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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