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

NCT ID: NCT00209729

Last Updated: 2010-05-26

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2010-03-31

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.

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Docetaxel plus S-1

Group Type: EXPERIMENTAL

Taxotere

Intervention Type: DRUG

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

TS-1

Intervention Type: DRUG

Day 1-14, P.O. everyday

Interventions

Taxotere

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

Intervention Type: DRUG

TS-1

Day 1-14, P.O. everyday

Intervention Type: DRUG

Other Intervention Names

Docetaxel; S-1

Eligibility Criteria

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.

• Minimum Eligible Age: 76 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hokkaido University Hospital

OTHER

Sponsor Role: collaborator

Hokkaido Gastrointestinal Cancer Study Group

OTHER

Sponsor Role: lead

Responsible Party

Hokkaido University Hospital Cancer Center

Principal Investigators

Masahiro Asaka, MD, PhD

Role: STUDY_CHAIR

Hokkaido Gastrointestinal Cancer Study Group

Locations

Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)

Sapporo, Hokkaido, Japan

Countries

Japan

Other Identifiers

DS-Elderly

Identifier Type: -

Identifier Source: secondary_id

HGCSG0502

Identifier Type: -

Identifier Source: org_study_id