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

NCT00155883 | Terminated Phase 2

• 1 other identifier: 921101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• tumor response rate

Secondary Outcomes (1)

• clinical benefit response, toxicities, quality of life, time to disease progression, overall survival

Interventions

Taxteral DRUG

5-Fluorouracil DRUG

Leucovorin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven and inoperable advanced gastric adenocarcinoma.
• 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.
• Age must be older than 18 and younger than 75 year-old.
• Karnofsky performance status\>60% (see Appendix)
• Adequate bone marrow reserves, defined as white blood cell (WBC)\>4,000/l, absolute neutrophil count (ANC)\>1,500/l, platelet\>100,000/l.
• 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.
• Serum triglyceride level\>70mg/dl.
• 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.
• Previous radiotherapy is allowed if the treatment was completed at least 4 weeks before the enrollment into this study.
• Patients of childbearing age should have effective contraception during the study period.
• 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.

You may not qualify if:

• Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.
• Patients who refuse port-A catheter implantation.
• Patients with brain or leptomeningeal metastases.
• Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.
• Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.
• Life expectancy of less than 2 months.
• 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.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Oncology, Nationa Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ann-Lii Cheng

  Department of Oncology , National Taiwan University Hospital

  STUDY CHAIR

• Ann-Lii Cheng

  Department of Oncology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: June 1, 2004
• Study Completion: July 1, 2005
• Last Updated: August 18, 2008

Record last verified: 2005-07

Locations

TW (1)