Chemotherapy for Patients With Cancer of the Stomach

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

— DOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928524
• Other study ID #: KFE 12.17
• Status: Completed
• Phase: Phase 1
• Start date: September 2013
• Est. completion date: December 17, 2015

Study information

• Verified date: January 2021
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 17, 2015
• Est. primary completion date: June 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
• Stomach Neoplasms

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Per Pfeiffer

Country where clinical trial is conducted

Denmark, 

References & 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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Overall Survival		Up to 2 years after first administration of DOS