Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.

Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer. - Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000502

Enrollment

Registered

2006-10-14

Start date

2006-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with metastatic or recurrent gastric cancer

Interventions

5-FU Level 0 : 400mg/m2 bolus Level 1,2: 500mg/m2 bolus Level 3,4: 600mg/m2 bolus l-Leucovorin Level 0 : 200mg/m2/120min Level 1-4: 250mg/m2/120min Paclitaxel Level 0,1: 60mg/m2/60min Leve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed gastric adenocarcinoma 2) Age between 20 and 75 years 3) ECOG performance status (PS) of 0 to 2 4) Measurable disease by Response Evaluation Criteria in Solid Tumors Group (RECIST) 5) A life expectancy of at least 8 weeks 6) No prior chemotherapy or radiation therapy for gastric cancer, except follows; 1. Only oral fluoropyrimidine drug 2. Within 1 regimen 3. Administered for less than 1 year 4. Finished more than 6 months before 7) No prior chemotherapy or radiation therapy for other than gastric cancer 8) Adequate organ function 1. WBC>=3,000/mm3,<=12,000/mm3 2. platelets>=100,000/mm3 3. GOT, GPT<=100 U/L 4. T-Bil<=2.0 mg/dL 5. Cr<=1.5 mg/dL 6. CRP<=10mg/dL 9) No blood transfusion in last 2 weeks 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Diabetes with regular use of insulin or under poor control 2) Active ischemic heart disease 3) Severe arrhythmia 4) Symptomatic brain metastasis 5) Alcohol allergy 6) HBs antigen positive or HCV antibody positive 7) Massive abdominal effusion 8) Massive pleural effusin 9) Severe diarrhea 10) History of other active malignancy 11) Pregnancy, the desire to preserve fecundity, or lactating woman 12) Severe mental disorder 13) Need of IVH or enteral nutrition 14) Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
Phase I : Rate of dose limiting toxicity Phase II: Response rate	—

Secondary

Measure	Time frame
Toxicity Time to treatment failure Overall survival	—

Countries

Japan

Contacts

Public ContactJunichi Matsubara

National Cancer Center Hospital Gastrointestinal Oncology Division

jmatsuba@kuhp.kyoto-u.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026