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An Open,Multi-Center,Phase II Clinical Trial tO Evaluate Efficacy and Safety oF TAXOL(PACLITAXEL),UFT,and LEUCOVORIN in Patients With Advanced Gastric Cancer

Phase 2
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

An Open,Multi-Center,Phase II Clinical Trial tO Evaluate Efficacy and Safety oF TAXOL(PACLITAXEL),UFT,and LEUCOVORIN in Patients With Advanced Gastric Cancer

Since 1982,cancer has been the leading cause of death in Taiwan. In particular,gastric
cancer is the fourth leading cause of death in male cancer patients and the sixth for female
patients in 2000,accounting for an estimated 2,374 deaths. In recent years, the treatment of
gastric cancer patients has gradually been improving due to advances in early diagnosis and
surgical techniques. Although chemotherapy and radiation therapy have been used in either
the adjuvant or palliative setting, their values are still limited due to their unacceptable
toxicity or inadequate efficiency.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response rate

Outcome Time Frame:


Principal Investigator

Kun-Huei Yeh, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

March 2003

Completion Date:

June 2005

Related Keywords:

  • Gastric Cancer
  • Combination,Chemotherapy,Advanced Gastric Cancer
  • Stomach Neoplasms