Chemotherapy for Patients With Cancer of the Stomach

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DOS2W Dose level 1A

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

Group Type EXPERIMENTAL

DOS2w Dose level 1A

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

DOS2w Dose level 2A

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

DOS2w Dose level 3A

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

DOS2w Dose level 4A

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

DOS3w Dose level 1B

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

DOS3w Dose level 2B

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

DOS3w Dose level 3B

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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DOS2w 1A DOS2w 2A DOS2w 3A DOS2w 4A DOS3w 1B DOS3w 2B DOS3w 3B

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No