Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer.

Gastric Cancer Clinical Trial

Official title:

Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00209729
• Other study ID #: HGCSG0502
• Secondary ID: DS-Elderly
• Status: Suspended
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: May 24, 2010
• Start date: April 2005
• Est. completion date: March 2010

Study information

• Verified date: May 2010
• Source: Hokkaido Gastrointestinal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric cancer.

Description:

A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on Elderly patients with histological stage IV gastric cancer given Docetaxel plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 76 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Histological diagnosis of gastric adenocarcinoma.

2. Measurable or assessable lesions(Except for Phase I).

3. Age: 76 ~ 80 years.

4. Performance Status (ECOG): 0 ~ 2.

5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.

6. No history of treatment with Docetaxel or S-1.

7. No history of radiotherapy to the abdomen.

8. Oral intake of S-1 is possible.

9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5 times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).

10. Predicted survival for >3 months.

11. Able to give written informed consent.

Exclusion Criteria:

1. Severe pleural effusion or ascites.

2. Metastasis to the central nervous system (CNS).

3. Active gastrointestinal bleeding.

4. Active infection.

5. Diarrhea (watery stools).

6. Uncontrolled ischemic heart disease.

7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).

8. Active multiple cancer.

9. Severe mental disorder.

10. Pregnancy, possible pregnancy, or breast-feeding.

11. Flucytosine treatment.

12. Judged to be ineligible for this protocol by the attending physician.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Taxotere
X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.
• TS-1
Day 1-14, P.O. everyday

Locations

Country	Name	City	State
Japan	Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)	Sapporo	Hokkaido

Sponsors (2)

Lead Sponsor	Collaborator
Hokkaido Gastrointestinal Cancer Study Group	Hokkaido University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.		1-year	Yes
Secondary	Determine the clinical response rate of patients in Phase I setting.		1-year	Yes
Secondary	Determine the OS(Overall Survival) and DFS(Disease Free Survival).		2-years	Yes