Status:
UNKNOWN
An Effective and Well-Tolerated Regimen of Docetaxel Plus High-Dose 5-Fluorouracil and Leucovorin(HDFL)to Treat Inoperable Advanced or Metastatic Gastric Cancer
Lead Sponsor:
Far Eastern Memorial Hospital
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary endpoint of this phase II trial is the objective tumor response rate. The secondary endpoints include treatment-related toxicity, the clinical benefit response defined by the change in per...
Detailed Description
The regimen consists of docetaxel, 50 mg/m2, 5-FU, 2400 mg/m2, and leucovorin, 240 mg/m2 on days 1 and 15. Docetaxel will be given by 1-hour intravenous infusion and 5-FU/leucovorin by 24-hour intrave...
Eligibility Criteria
Inclusion
- 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%. 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 1.5 mg/dl. 7.Serum triglyceride level 70 mg/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
- 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 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00270543
Last Update
February 9 2009
Active Locations (1)
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1
Kun-Huei Yeh
Taipei, Ban-Ciao, Taiwan, 220