Phase 1
N=34
Chemotherapy for Patients With Cancer of the Stomach
First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or
Bottom Line
View on ClinicalTrials.gov: NCT01928524 ↗Enrolled (actual)
34
Serious AEs
20.6%
Results posted
Feb 2021
Primary outcome: Primary: Median Overall Survival — 4.3; 13.8; 14.6; 15.2 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- DOS2w Dose level 1A (Drug); DOS2w Dose level 2A (Drug); DOS2w Dose level 3A (Drug); DOS2w Dose level 4A (Drug); DOS3w Dose level 1B (Drug); DOS3w Dose level 2B (Drug); DOS3w Dose level 3B (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Per Pfeiffer
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Overall Survival |
4.3; 13.8; 14.6; 15.2; 8.3; 16.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histological proven adenocarcinoma of the esophagus or the ventricle (ECV), and which cannot be treated curatively.
- Age ≥ 18 years.
- WHO performance status 0-1.
- Neutrophils ≥ 1, 5 x 109/L and platelets ≥ 100 x 109/L.
- Bilirubin ≤ 1, 5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL.
- Creatinine-clearance ≥ 60 ml/min.
- Planned first day of treatment within 8 days after inclusion in the study.
- Signed consent form.
Exclusion Criteria
- 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.
- No sensory neuropathy.
- No previously treatment with docetaxel, oxaliplatin or S1.
- No clinical suspicion of brain metastases.
- No cytotoxic treatment or other experimental treatment within 2 weeks of inclusion in the study.
- Other serious disease (i.e. heart disease, AMI within 1 year or ongoing infection).
- No pregnant women or women who are lactating. Patients who are not using contraception.
- No known DPD-deficiency or known allergy to taxanes or platinum.
- No signs of physical or mental illness that would prevent absorption of oral treatment.
Data sourced from ClinicalTrials.gov (NCT01928524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.