Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer
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|ClinicalTrials.gov Identifier: NCT00354224|
Recruitment Status : Terminated (due to low accrual)
First Posted : July 20, 2006
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: capecitabine Drug: oxaliplatin||Phase 2|
- Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin.
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer|
|Actual Study Start Date :||January 2005|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Experimental: Oxaliplatin + Capecitabine
Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.
- Response Rate as Determined by RECIST. [ Time Frame: Every 6 weeks through study completion for up to about 18 weeks ]Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Number of Adverse Events [ Time Frame: From the start of study treatment through study completion for up to about 18 weeks ]
- Progression-free Survival [ Time Frame: Every 6 weeks through study completion for up to about 18 weeks ]
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): NCT00354224
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Uzair B. Chaudhary, MD||Medical University of South Carolina|
|Study Chair:||Gustavo Leone||Medical University of South Carolina, Hollings Cancer Center|