Overview

Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer

Status:
Completed

Trial end date:
2005-06-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate the response rate of Paclitaxel combination chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Taiwan University Hospital

Collaborators:

Mackay Memorial Hospital
National Cheng-Kung University Hospital
National Health Research Institutes, Taiwan
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital

Treatments:

Albumin-Bound Paclitaxel
Leucovorin
Paclitaxel

Criteria

Inclusion Criteria:

1. At least 18 years old

2. Patients with histologically confirmed gastric adenocarcinoma, defined as locally
advanced unresectable or metastatic or recurrent disease

3. Patients with at least one measurable lesion

4. ECOG performance status of 0,1 or 2

5. Patients with no prior chemotherapy and radiotherapy for metastatic disease (patients
who have received and completed prior adjuvant chemotherapy at least 6 months prior to
study enrollment may be enrolled into the study, prior taxane chemotherapy should be
excluded)

6. Patients with physiological functions (bone marrow, heart, liver, kidney, etc.)
meeting the following criteria: WBC >4000/mm3, ANC >1500/mm3, PLT >100,000/mm3, Hb
>9.0g/dL, ALT<3 times the ULN (<5 times the ULN for liver metastasis cases), Total
bilirubin <1.5mg/dL, Creatinine
7. Accessible for treatment and follow-up

8. Give written informed consent

9. Women of child bearing potential must have a negative plasma or urine pregnancy test
within 72 hours prior to start of the study medication

Exclusion Criteria:

1. Patients who received surgery within 14 days prior to enrollment

2. Patients with CNS metastasis

3. History of hypersensitivity related to the administration of
polyoxyethylated-castor-oil (cremophor EL)-containing preparation (e.g.
cyclosporin,etc.) or hardened-castor-oil-containing preparation (e.g. vitamin
preparation for injection,etc.)

4. Patients with a history of severe hypersensitivity

5. Active infectious symptoms

6. Patients with active gastrointestinal bleeding, intestinal obstruction or other
situation that dose not allow oral intake of medication

7. Patients with ascites that adversely affects performance status

8. Pre-existing CTC Grade 2 or greater neuropathy (motor or sensory)

9. Pregnant or nursing females

10. Patients who have participated in other clinical trials within 30 days prior to the
first dose of the study drug