Xeloda Plus Paclitaxel in Gastric Cancer With Liver Metastasis

July 21, 2010 updated by: Peking University Cancer Hospital & Institute

Neoadjuvant Chemotherapy With Xeloda in Combination With Paclitaxel in Gastric Cancer With Liver Metastasis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100036
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  1. not fit for the inclusion criteria
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAPECITABINE

Single arm:

Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; repeat three cycles (approximately 3- months);
Drug: CAPECITABINE
Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; Repeat three cycles (approximately 3- months);
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided
Time Frame: 3 years from last patient enrolled
Primary Endpoint is PFS (progression free survival), tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided.
3 years from last patient enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Jiafu Ji, Post-Doctor, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Estimate)

July 22, 2010

Last Update Submitted That Met QC Criteria

July 21, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on CAPECITABINE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe