A Phase II Study of Docetaxel, Oxaliplatin and S-1 (DOS) in Patients With Advanced Gastric Cancer
18 Years
70 Years
Both
Stomach Neoplasms
Trial Information
A Phase II Study of Docetaxel, Oxaliplatin and S-1 (DOS) in Patients With Advanced Gastric Cancer
Docetaxel is an anti-microtubule agent. Docetaxel is an active agent for gastric cancer,
with response rate (RR) of 20-24% as a single agent and RR of 37-40% as a combination
therapy with 5-FU and/or cisplatin.
S-1 is a new oral dihydropyrimidine dehydrogenase (DPD) inhibitory fluoropyrimidine (DIF).
In two late phase II studies of S-1 for advanced gastric cancer, RR was 45%, with very low
(2%) incidence of grade 3 toxicity.
Recent phase I/II trial of the combination of docetaxel and S-1 in patients with advanced
gastric cancer suggests that repeated 3-4 week cycles of S-1 60-80mg/m2 /day for 14 days
combined with docetaxel 40-75mg/m2 is feasible.
Oxaliplatin, diaminocyclohexane-platinum, is an alkylating agent inhibiting DNA replication.
Comparing to cisplatin or carboplatin, oxaliplatin appear to be more effective and has a
more favorable toxicity profile. Phase II studies of the combination of docetaxel and
oxaliplatin in patients with advanced gastric cancer suggests that docetaxel 60 or 75mg/m2
combined with oxaliplatin 130 or 80mg/m2 every 3 weeks is feasible.
Recent dose finding study of the combination of docetaxel, oxaliplatin and S-1 (DOS) in
patients with advanced gastric cancer suggests that docetaxel 52.5mg/m2 on day 1 and
oxaliplatin 105mg/m2 on day 1 combined with S-1 80mg/m2 on day1 to day 14 every 3 weeks is
feasible.
Docetaxel, S-1 and oxaliplatin have distinct mechanisms of action and no overlapped key
toxicities. Furthermore, fluoropyrimidine and docetaxel or oxaliplatin have shown synergism
in vivo studies and in clinical trials. Based on these results, the combination of DOS is a
reasonable candidate of new chemotherapeutic regimen for the advanced gastric cancer.
Inclusion Criteria:
- Histologically confirmed gastric adenocarcinoma, initially diagnosed or recurred
- Unresectable, locally advanced or metastatic
- At least one uni-dimensional measurable lesion by RECIST criteria
- Age 18 to 70 years old
- ECOG performance status ≤2
- Estimated life expectancy ≥3 months
- Adequate bone marrow function (WBCs ≥4,000/µL or absolute neutrophil count
≥1,500/µL, platelets ≥100,000/µL),
- Adequate kidney function (creatinine <1.5 mg/dL)
- Adequate liver function (bilirubin ≤1.8 mg/dL, transaminase levels <2 times the upper
normal limit
- Written informed consent
Exclusion Criteria:
- Other tumor type than adenocarcinoma
- Previous history of chemotherapy (exception: adjuvant chemotherapy)
- Presence of CNS metastasis, psychosis, or seizure
- Obvious bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy (NCI CTC >= Grade I)
- Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for
curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate
contraception
- Other serious illness or medical conditions
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall response rate
Outcome Time Frame:
2.5 years
Safety Issue:
No
Principal Investigator
Dae Young Zang, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hallym University Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
HMC-HO-GI-0701
NCT ID:
NCT00525005
Start Date:
August 2007
Completion Date:
June 2010
Related Keywords:
- Stomach Neoplasms
- Stomach Neoplasm
- Docetaxel
- Oxaliplatin
- S-1
- Neoplasms
- Stomach Neoplasms
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