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

Sponsor

Hokkaido Gastrointestinal Cancer Study Group (Other)

Overall Status

Suspended

CT.gov ID

NCT00209729

Collaborator

Hokkaido University Hospital (Other)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Taxotere Drug: TS-1	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2005

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Docetaxel plus S-1	Drug: Taxotere X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle. Other Names: Docetaxel Drug: TS-1 Day 1-14, P.O. everyday Other Names: S-1

Arm

Intervention/Treatment

Experimental: 1

Docetaxel plus S-1

Drug: Taxotere

X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.

Other Names:

Docetaxel

Drug: TS-1

Day 1-14, P.O. everyday

Other Names:

S-1

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Determine the clinical response rate of patients in Phase I setting. [1-year]
Determine the OS(Overall Survival) and DFS(Disease Free Survival). [2-years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

76 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological diagnosis of gastric adenocarcinoma.
Measurable or assessable lesions(Except for Phase I).
Age: 76 ~ 80 years.
Performance Status (ECOG): 0 ~ 2.
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.
No history of treatment with Docetaxel or S-1.
No history of radiotherapy to the abdomen.
Oral intake of S-1 is possible.
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).
Predicted survival for >3 months.
Able to give written informed consent.

Exclusion Criteria:

Severe pleural effusion or ascites.
Metastasis to the central nervous system (CNS).
Active gastrointestinal bleeding.
Active infection.
Diarrhea (watery stools).
Uncontrolled ischemic heart disease.
Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
Active multiple cancer.
Severe mental disorder.
Pregnancy, possible pregnancy, or breast-feeding.
Flucytosine treatment.
Judged to be ineligible for this protocol by the attending physician.