Sequential Chemotherapy With Xelox Follows by TX to Treat Gastric Cancer

April 7, 2011 updated by: Taipei Veterans General Hospital, Taiwan

A Phase II Study of Sequential Capecitabine Plus Oxaliplatin (XELOX) Followed by Docetaxel Plus Capecitabine (TX) in Patients With Unresectable Gastric

The purpose of this study is to determine whether sequential chemotherapy with capecitabine plus oxaliplatin (Xelox) followed by docetaxel plus capecitabine (TX)in unresectable gastric cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is one of the most frequent cancer types in Taiwan. Advanced gastric cancer is incurable. Although chemotherapy can improve survival and maintain quality of life for patients with advanced gastric cancer, optimal chemotherapy for this disease has not been defined.

Cytotoxic agents commonly used in this disease include platinum compounds, fluoropyrimidines and taxanes. A phase III (V325) study showed that adding docetaxel to cisplatin and 5-FU (TCF) improved response rates, progression-free survival (PFS), and overall survival (OS). Although the TCF regimen improved clinical outcomes, it was associated with substantial toxicity particularly that related to myelosuppression, with a 29% incidence of febrile neutropenia or neutropenic infection1. Several modifications to the TCF regimen have been made to maintain efficacy and reduce toxicity.

Cunningham et al. evaluated the impact of substituting oxaliplatin for cisplatin and capecitabine for 5-FU in the epirubicin, cisplatin, and 5-FU (ECF) regimen. Oxaliplatin as compared with cisplatin demonstrated comparable efficacy, with a lower incidence of myelosuppression, thromboembolic complications, and nephrotoxicity. The combination of docetaxel and oxaliplatin has been evaluated in gastric cancer with moderate activities in four phase II trials.

A different way of including all active agents in the first line treatment of advanced gastric cancer is to use them sequentially. Sequential schedules may maximize the dose-intensity of each single agent and avoid the overlapping toxicity caused by the concomitant administration of active drugs. Two studies using sequential strategy to treat advanced gastric cancer were reported.7-8 One used docetaxel after PELF regimen, the other used cisplatin plus 5-Fluorouracil / leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV, followed by docetaxel plus 5-FU/LV. Both studies shown that sequential approach produced a good treatment efficacy with manageable toxicities in the management of advanced gastric cancer.

In our hospital, we had completed two phase II studies in advanced gastric cancer, including XELOX (capecitabine plus oxaliplatin) and a modified TCF regimen (docetaxel plus cisplatin and oral tegafur/uracil plus leucovorin). After analyzing these results, the median time to response, time to progression and overall survival were around 3, 6, and 10 months, respectively. Overall response rate was around 50% for each.

Based on the above considerations and our previous experiences, we hence initiate this phase II study to evaluate the feasibility and the anti-tumor activity of a new strategy consists of two sequential regimens involving XELOX and TX in unresectable gastric cancer.

Study Type

Interventional

Enrollment (Anticipated)

51

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

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Yee Chao, MD.PHD
        • Sub-Investigator:
          • Ming-Huang Chen, MD
        • Sub-Investigator:
          • Chung-Pin Li, MD.PHD

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically confirmed gastric adenocarcinoma.
  • At least one measurable lesion in a non-irradiated area.
  • No prior exposure to systemic chemotherapy for advanced gastric cancer.
  • For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
  • Aged > 20 years old.
  • ECOG Performance Status <= 2.
  • Life expectancy greater than 12 weeks.
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate renal function

Exclusion Criteria:

  • Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy. (Previous radiotherapy is allowable if the last dose was given more than 1 month before the protocol treatment).
  • Major surgery within two weeks prior to entering the study.
  • Patients with CNS metastasis, including clinical suspicion.
  • Patients who are under active or uncontrolled infections.
  • Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
  • Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria
  • Patients with concomitant illness that might be aggravated by chemotherapy.
  • Patients who are pregnant or with breast feeding.
  • Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
  • Patients with hypersensitivity to any component of the chemotherapeutic regimen.
  • mental status is not fit for clinical trial
  • can not take study medication orally
  • fertile men and women unless using a reliable and appropriate contraceptive method

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, Oxaliplatin, Docetaxel , Gastric cancer
Drug: Capecitabine (Xeloda, Roche), Oxaliplatin (Sanofi-Aventis), Docetaxel (Sanofi-Aventis)
capecitabine orally 1000 mg/m2 twice daily, day1 to day 10, every 2 weeks plus oxaliplatin 85mg/m2 (2hrs IV infusion)on day1, every 2 weeks for 6 cycles, then shift to docetaxel 30 mg/m2(over 30-minute intravenous infusion) on day 1 and day 8 plus oral capecitabine 825 mg/m2 twice daily on day 1 to 14, every 3 weeks for 4 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective tumor response rate
Time Frame: 2 year
Analysis for the objective response rate will be conducted on both the intention-to-treat (ITT) and evaluable data sets. Response will be assessed by Response Evaluation Criteria in Solid Tumor (RECIST 1.1).The analysis will be in descriptive statistics, presented by point estimate and 95% confidence interval for the efficacy variable (Objective tumor response rate)
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the progression-free survival, overall survival, toxicity profiles
Time Frame: 2 year

The progression-free survival is defined as the duration between the time from the date of randomization to the date of first observed progressive disease or death due to any cause. The overall survival is defined as the duration between the time from the date of randomization to the date of death due to any cause.

Toxicity profiles: measure numbers of participants with adverse events. Treatment toxicity will be graded by NCI Common Toxicity Criteria Version 4.0 (CTC,v4.0) for safety evaluation.
2 year

Collaborators and Investigators

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

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Yee Chao, MD,PHD, attending physician, cancer center, Taipei Veterans General Hospital

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

January 1, 2011

Primary Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimate)

April 8, 2011

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOH99-TD-C-111-007

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.

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