Chemotherapy for Patients With Cancer of the Stomach

• Status: Completed
• Trial end date: 2015-12-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Per Pfeiffer
• Collaborators: Nordic Group BV; Taiho Pharmaceuticals CO Ltd.
• Treatments: Docetaxel; Oxaliplatin

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.