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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154778
• Other study ID #: 910703
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: July 30, 2007
• Start date: March 2003
• Est. completion date: June 2005

Study information

• Verified date: July 2005
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 <the upper limit of normal

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Taxol, UFT,Leucovorin

Locations

Country	Name	City	State
Taiwan	Department of Oncology, Nationa Taiwan University Hospital	Taipei

Sponsors (6)

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

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Chao Y, Li CP, Chao TY, Su WC, Hsieh RK, Wu MF, Yeh KH, Kao WY, Chen LT, Cheng AL. An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer. Br J Cancer. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the response rate		2003~2004
Secondary	To determine time to progression and safety		2004~2005

External Links

•   An open, multi-centre, phase II clinical trial to evaluate the efficacy and safety of paclitaxel, UFT, and leucovorin in patients with advanced gastric cancer.