Xeloda Plus Paclitaxel in Gastric Cancer With Liver Metastasis

NCT ID: NCT01167049

Last Updated: 2010-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-12-31

Brief Summary

To investigate the efficacy of capecitabine combined with paclitaxel as neoadjuvant chemotherapy for gastric cancer with liver metastasis only

Detailed Description

Patients with advanced or metastatic gastric cancer have a poor prognosis. The optimal treatment of gastric cancer with liver metastases without other distant metastases remains a matter for debate and there are few prospective clinical trials to explore this area. The aim of this prospective phase II study is to evaluate the optimal treatment of gastric cancer with liver metastases.

In preclinical xenograft models, capecitabine was highly active against several tumors, including breast, colorectal, gastric, and cervical tumors, and against both 5-FU-sensitive and 5-FU-resistant tumors. Intermittent capecitabine (1250 mg/m2 daily dose for 14 days, followed by a 7-day rest period) was shown to be active as a single agent in previously untreated AGC patients, with a response rate of 28.2% in 39 patients. The combination of capecitabine with other drugs, such as cisplatin, oxaliplatin, epirubicin, and docetaxel, had an objective response rate of 40-68% as first-line treatment in patients with AGC.

In human colon cancer xenograft model, thymidine phosphorylase is upregulated and synergy between paclitaxel and capecitabine has been observed. The activity of capecitabine in patients with breast cancer refractory to paclitaxel and anthracyclines suggests that the combination of capecitabine and paclitaxel may be effective in treating patients with advanced breast cancer. Doses recommended are capecitabine 1650 mg/m2 per day orally for 14 days and paclitaxel 175 mg/m2 i.v. every 3 weeks.

In a phase II trial with 45 patients involved, 2 patients showed complete response and 20 showed partial response making the overall response rate 48.9% (95%CI:30.3-63.5%). There was no neutropaenic fever or treatment-related deaths. That study demonstrated that paclitaxel and capecitabine combination chemotherapy was active and highly tolerable.

The rationale of this study was to find out if outcome could be improved after neoadjuvant chemotherapy with paclitaxel and capecitabine with or without local treatment for patients without other distant metastasis than liver metastasis.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAPECITABINE

Single arm:

Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; repeat three cycles (approximately 3- months);

Group Type: EXPERIMENTAL

CAPECITABINE

Intervention Type: DRUG

Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; Repeat three cycles (approximately 3- months);

Interventions

CAPECITABINE

Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; Repeat three cycles (approximately 3- months);

Intervention Type: DRUG

Other Intervention Names

Xeloda

Eligibility Criteria

Inclusion Criteria

1. Ambulatory males or females, aged no less than 18 years.

2. ECOG performance status: 0-1.

3. Histologically confirmed gastric adeno-carcinoma.

4. Radiologically confirmed liver metastasis without other distant metastasis.

5. No serious concomitant medical illnesses

6. Life expectancy more than 3 months

7. Be willing and able to comply with the protocol for the duration of the study

8. No Prior treatment for metastatic disease

9. Give signed informed consent

2. not able to comply with the protocol

3. with high risks which may compromise the benefit of proposed regimen

4. Active (significant or uncontrolled) gastrointestinal bleeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Beijing Cancer Hosptial

Principal Investigators

Jiafu Ji, Post-Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiafu Ji, Post-Doctor

Role: CONTACT

jiafuj@hotmail.com

86 21 88196048

Facility Contacts

Aiwen Wu, MD

Role: primary

wuaw@sina.com

86 10 88196050

Other Identifiers

ML22199

Identifier Type: -

Identifier Source: org_study_id