Bi-Weekly Docetaxel Plus 24-Hour Infusion of High-Dose 5-Fluorouracil / Leucovorin (HDFL) for Inoperable Advanced or Metastatic Gastric Cancer

• Status: Terminated
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of high-dose 5-FU/leucovorin chemotherapy for patients with inoperable advanced gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Docetaxel; Fluorouracil; Leucovorin

Criteria

Inclusion Criteria:

1. Histologically proven and inoperable advanced gastric adenocarcinoma.

2. Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography scan). The index lesions should be at least 20 mm × 10 mm in size.

3. Age must be older than 18 and younger than 75 year-old.

4. Karnofsky performance status>60% (see Appendix)

5. Adequate bone marrow reserves, defined as white blood cell (WBC)>4,000/l, absolute neutrophil count (ANC)>1,500/l, platelet>100,000/l.

6. Liver transaminases <2.5 times upper normal limit if no liver metastasis and 5 times upper normal limit if liver metastasis is present; total bilirubin <1.5 mg/dl; serum creatinine<1.5mg/dl.

7. Serum triglyceride level>70mg/dl.

8. Previous chemotherapy for metastatic disease is not allowed in this study. Previous adjuvant chemotherapy following curative gastrectomy is acceptable if the adjuvant chemotherapy has been completed for more than 6 months before enrollment into the present study.

9. Previous radiotherapy is allowed if the treatment was completed at least 4 weeks before the enrollment into this study.

10. Patients of childbearing age should have effective contraception during the study period.

11. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

1. Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.

2. Patients who refuse port-A catheter implantation.

3. Patients with brain or leptomeningeal metastases.

4. Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.

5. Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.

6. Life expectancy of less than 2 months.

7. Pregnant or nursing women may not participate. Women or men with reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

8. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any cancer from which the patient has been disease-free for 5 years.