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Stomach NeoplasmsPhase 2NCT00525005

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

A Phase 2 study testing DOS (Docetaxel, Oxaliplatin and S-1) in people with Stomach Neoplasms, run by Hallym University Medical Center at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
DOS (Docetaxel, Oxaliplatin and S-1)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesSouth Korea
Study dates
Aug 2007to Jun 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Hallym University Medical Center

    Anyang, 431-070

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Phase II Study of Docetaxel, Oxaliplatin and S-1 (DOS) in Patients With Advanced Gastric Cancer

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.

Being tested
DOS (Docetaxel, Oxaliplatin and S-1)
Keywords
Stomach Neoplasm, Docetaxel, Oxaliplatin, S-1
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Taxotere, Eloxatin, TS-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)

Study groups in NCT00525005
Study groupRoleWhat they receive
DOS (Docetaxel, Oxaliplatin and S-1)ExperimentalDocetaxel 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)
Receives: Drug: DOS (Docetaxel, Oxaliplatin and S-1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate

    Measured: 2.5 years

Secondary outcomes (1)

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

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00525005
Sponsor's protocol ID
HMC-HO-GI-0701
Status last verified
Sep 2012
First submitted
4 Sep 2007
Last updated
21 Sep 2012
Results posted
No
Data monitoring committee
No

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 DY, Yang DH, Lee HW, Hwang SW, Song HH, Jung JY, Kwon JH, Kim HJ, Kim JH, Park SR, Kim MJ, Jang KM, Park CK, Kim JH, Lee BH. Phase I/II trial with docetaxel and S-1 for patients with advanced or recurrent gastric cancer with consideration to age. Cancer Chemother Pharmacol. 2009 Feb;63(3):509-16. doi: 10.1007/s00280-008-0768-9. Epub 2008 May 15.

    PubMed 18481067

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DOS (Docetaxel, Oxaliplatin and S-1) in people with Stomach Neoplasms, run by Hallym University Medical Center at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (time frame: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00525005, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2012.

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