Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer

Phase 2

Terminated

• Conditions: Colorectal Cancer

• Registration Number: NCT00276861
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.

Secondary

* 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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Primary Completion: 2006-09
• Study Completion: 2008-05
• Results First Submitted: 2013-01-22
• Results First Submitted QC: 2013-01-22
• Results First Posted: 2013-02-26
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response Rate as Measured by RECIST Criteria	4 - 6 months	Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

Secondary Outcome Measures

Name	Time	Method
Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment	6 months	Number of months from time of enrollment to the date of first documented progression or date of death.

Trial Locations

Locations (1)

University of Miami Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States