Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-30 @ 4:32 PM
Study NCT ID:
NCT00276861
Status:
TERMINATED
Last Update Posted:
2017-02-08
First Post:
2006-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: