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Xeloda Plus Paclitaxel in Gastric Cancer With Liver Metastasis

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ClinicalTrials.gov Identifier: NCT01167049
Recruitment Status : Unknown
Verified July 2010 by Beijing Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
Roche Pharma AG
Information provided by:
Beijing Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: CAPECITABINE Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy With Xeloda in Combination With Paclitaxel in Gastric Cancer With Liver Metastasis
Study Start Date : August 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

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);

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167049

Contact: Jiafu Ji, Post-Doctor 86 21 88196048 jiafuj@hotmail.com

China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100036
Contact: Aiwen Wu, MD    86 10 88196050    wuaw@sina.com   
Sponsors and Collaborators
Beijing Cancer Hospital
Roche Pharma AG
Principal Investigator: Jiafu Ji, Post-Doctor Beijing Cancer Hospital

Responsible Party: Ji Jiafu/professor, Beijing Cancer Hosptial
ClinicalTrials.gov Identifier: NCT01167049     History of Changes
Other Study ID Numbers: ML22199
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010

Keywords provided by Beijing Cancer Hospital:
gastric cancer with liver metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Stomach Neoplasms
Neoplastic Processes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic