Chemotherapy for Patients With Cancer of the Stomach
Conditions
First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
Conditions: official terms
Esophageal Neoplasms - Stomach Neoplasms
Conditions: Keywords
Gastric cancer, Cancer of the esophagus, Oxaliplatin, Docetaxel, S1
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: DOS2W Type: Drug
Name: DOS3W Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
Odense University Hospital
Odense, Denmark
Status: Recruiting
Contact: Per Pfeiffer, Professor - +45 6541 2921 - per.pfeiffer@rsyd.dk
Start Date
September 2013
Completion Date
August 2016
Sponsors
Per Pfeiffer
Source
Odense University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page