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

NCT00525005 | Completed Phase 2

• 1 other identifier: HMC-HO-GI-0701
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stomach Neoplasms

Keywords

Stomach Neoplasm; Docetaxel; Oxaliplatin; S-1

Outcome Measures

Primary Outcomes (1)

• overall response rate

  2.5 years

Secondary Outcomes (1)

• safety, progression-free survival, and overall survival

  2.5 years

Study Arms (1)

DOS (Docetaxel, Oxaliplatin and S-1)

EXPERIMENTAL

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

DOS (Docetaxel, Oxaliplatin and S-1) DRUG

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

DOS (Docetaxel, Oxaliplatin and S-1)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Medical Center: lead
• Asan Medical Center: collaborator
• Sanofi: collaborator

Study Sites (2)

Hallym University Medical Center

Anyang, 431-070, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (6)

• 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.

  PMID: 16773074 BACKGROUND

• 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.

  PMID: 16740764 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17577620 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Oxaliplatin; S 1 (combination); titanium silicide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Dae Young Zang, MD, PhD

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

KR (2)