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CompletedNCT00525005Updated Sep 21, 2012

Docetaxel, Oxaliplatin and S-1 (DOS) for Advanced Gastric Cancer

A Phase 2 interventional study of DOS (Docetaxel, Oxaliplatin and S-1) in Stomach Neoplasms, sponsored by Hallym University Medical Center. Completed at 2 sites in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-09-21.

Sponsored by Hallym University Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy of combination of docetaxel, oxaliplatin, and S-1 (DOS) in the treatment of advanced gastric cancer.

Read the detailed description

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.

02

Conditions studied

  • Stomach Neoplasms

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Keywords

  • Stomach Neoplasm
  • Docetaxel
  • Oxaliplatin
  • S-1
03

In context

Stomach Neoplasms

2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's enrollment of 44 is below the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Hallym University Medical Center is the lead sponsor of 52 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    DOS (Docetaxel, Oxaliplatin and S-1)

    Docetaxel 52.5mg/m2 IV on D1 (diluted in 250 ml of normal saline over a 1 hour of each cycle before oxaliplatin) Oxaliplatin 105mg/m2 IV on D1 (diluted in 250 ml of 5% DW for 2 hours) S-1 80mg/m2/day on D1-14 (2 weeks of treatment followed by a 1-week rest period)

    Drug: DOS (Docetaxel, Oxaliplatin and S-1)

Interventions

  • DrugDOS (Docetaxel, Oxaliplatin and S-1)

    Docetaxel 52.5mg/m2 IV on D1 (diluted in 250 ml of normal saline over a 1 hour of each cycle before oxaliplatin) Oxaliplatin 105mg/m2 IV on D1 (diluted in 250 ml of 5% DW for 2 hours) S-1 80mg/m2/day on D1-14 (2 weeks of treatment followed by a 1-week rest period)

    Also known as: Taxotere, Eloxatin, TS-1

06

What researchers measure

Primary outcomes

  1. overall response rate

    Time frame: 2.5 years

Secondary outcomes

  1. safety, progression-free survival, and overall survival

    Time frame: 2.5 years

07

Study locations

2 sites
  • Hallym University Medical Center
    Anyang, 431-070, Korea, Republic of
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
08

References and documents

Publications

  • Yamaguchi K, Shimamura T, Hyodo I, Koizumi W, Doi T, Narahara H, Komatsu Y, Kato T, Saitoh S, Akiya T, Munakata M, Miyata Y, Maeda Y, Takiuchi H, Nakano S, Esaki T, Kinjo F, Sakata Y. Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer. 2006 Jun 19;94(12):1803-8. doi: 10.1038/sj.bjc.6603196. PubMed 16773074 ↗
  • Yoshida K, Ninomiya M, Takakura N, Hirabayashi N, Takiyama W, Sato Y, Todo S, Terashima M, Gotoh M, Sakamoto J, Nishiyama M. Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. Clin Cancer Res. 2006 Jun 1;12(11 Pt 1):3402-7. doi: 10.1158/1078-0432.CCR-05-2425. PubMed 16740764 ↗
  • Zang D, Song H, Kwon J, Jung J, Kim H, Kim J, Shin H, Park Y. Phase I/II trial with docetaxel and S-1 for patients with advanced or recurrent gastric cancer. Ann Oncol. 2006 Sep 29;17(S9):ix314, Abs:1097P
  • Richards D, Wilfong L, Sborov M, McCollum D, Khan M, Boehm K, Zhan F. Phase II trial of docetaxel+oxaliplatin in advanced gastroesophageal and/or stomach cancer. 7th World Congr Gastrointest cancer. 2005: Abs: P-143
  • Barone C, Basso M, Schinzari G, Pozzo C, Trigila N, D'Argento E, Quirino M, Astone A, Cassano A. Docetaxel and oxaliplatin combination in second-line treatment of patients with advanced gastric cancer. Gastric Cancer. 2007;10(2):104-11. doi: 10.1007/s10120-007-0415-x. Epub 2007 Jun 25. PubMed 17577620 ↗
  • Zang D, Yang D, Lee H, Lee B, Hwang S, Kim H, Song H, Jung J, Kim J, Kwon J. Phase I study of docetaxel, oxalipaltin and S-1 (DOS) for patients with advanced gastric cancer. Ann Oncol 2007 Sep 23; Abs:in press
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00525005
Lead sponsor
Hallym University Medical Center
Collaborators
Asan Medical Center, Sanofi
Responsible party
Sponsor
First posted
Sep 5, 2007
Start date
Aug 2007
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Sep 21, 2012

Study contacts

Dae Young Zang, MD, PhD
principal investigator · Hallym University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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