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Chemotherapy for Patients With Cancer of the Stomach (DOS)

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ClinicalTrials.gov Identifier: NCT01928524
Recruitment Status : Completed
First Posted : August 26, 2013
Last Update Posted : February 8, 2017
Sponsor:
Collaborators:
Taiho Pharmaceuticals CO Ltd.
Nordic Group BV
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or Drug: DOS2W Drug: DOS3W Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2013
Actual Primary Completion Date : June 5, 2015
Actual Study Completion Date : December 17, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: DOS2W
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2nd week.
Drug: DOS2W
Docetaxel (30-35 mg/m2), Oxaliplatin (70 mg/m2) and S1 (30-50 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

Experimental: DOS3W
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3rd week.
Drug: DOS3W
Docetaxel (25 mg/m2), Oxaliplatin (100 mg/m2) and S1 (40-60 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




Primary Outcome Measures :
  1. Maximum tolerable dose (MTD) [ Time Frame: 2-3 weeks after first administration of DOS ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928524


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Per Pfeiffer
Taiho Pharmaceuticals CO Ltd.
Nordic Group BV
Investigators
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Study Chair: Per Pfeiffer, Professor Odense University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Per Pfeiffer, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01928524    
Other Study ID Numbers: KFE 12.17
First Posted: August 26, 2013    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Keywords provided by Per Pfeiffer, Odense University Hospital:
Gastric cancer
Cancer of the esophagus
Oxaliplatin
Docetaxel
S1
Additional relevant MeSH terms:
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Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases