Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer
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|ClinicalTrials.gov Identifier: NCT00276861|
Recruitment Status : Terminated (Low Accrual)
First Posted : January 13, 2006
Results First Posted : February 26, 2013
Last Update Posted : February 8, 2017
RATIONALE: Drugs used in chemotherapy, such as gemcitabine 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 gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: gemcitabine hydrochloride Drug: oxaliplatin||Phase 2|
- Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.
- Determine the overall and failure-free survival of patients treated with the chemotherapy regimen.
- Determine the duration of response (complete or partial) in patients treated with this regimen.
- Determine the percentage of patients who experience a 50% fall of serum carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving this regimen.
- Evaluate the toxicity associated with the administration of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||May 2008|
- Response Rate as Measured by RECIST Criteria [ Time Frame: 4 - 6 months ]Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.
- Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment [ Time Frame: 6 months ]Number of months from time of enrollment to the date of first documented progression or date of death.
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): NCT00276861
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Study Chair:||Caio Max S. Rocha Lima, MD||University of Miami Sylvester Comprehensive Cancer Center|