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

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

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.

Study Overview

• Status: Suspended
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Taxotere; Drug: TS-1

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8638
      • Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 76 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hokkaido Gastrointestinal Cancer Study Group
• Collaborators: Hokkaido University Hospital
• Investigators: Study Chair: Masahiro Asaka, MD, PhD, Hokkaido Gastrointestinal Cancer Study Group

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): March 1, 2010

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): May 26, 2010
• Last Update Submitted That Met QC Criteria: May 24, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Docetaxel; Gastric cancer; S-1; Elderly Patients
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: HGCSG0502; DS-Elderly