Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004190
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2000-01-21
Brief Title:
Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase ILimitedPhase II Study of Oxaliplatin OXAL and Gemcitabine GEMZAR in Patients With Metastatic Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine and oxaliplatin in treating patients who have refractory locally advanced or metastatic pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine and oxaliplatin in treating patients who have refractory locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES I Determine the safety and tolerability of gemcitabine plus oxaliplatin in patients with refractory metastatic or locally advanced pancreatic cancer phase I portion of the study closed as of 7500 II Determine the objective tumor response rate to this combination regimen in this patient population
OUTLINE This is a dose escalation and efficacy study Patients receive gemcitabine IV over 30 minutes on days 1 and 8 immediately followed by oxaliplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks Patients achieving stable disease partial response or regressive disease continue with therapy Patients achieving complete response for two consecutive evaluations receive an additional 2 courses of therapy Phase I closed as of 7500 Cohorts of 3-6 patients receive escalating doses of gemcitabine and oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Phase II Patients receive the MTD of gemcitabine and oxaliplatin as in phase I Patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 32-52 patients 12 patients to phase I phase I closed as of 7500 and 20-40 to phase II will be accrued for this study within approximately 11-28 months
OUTLINE This is a dose escalation and efficacy study Patients receive gemcitabine IV over 30 minutes on days 1 and 8 immediately followed by oxaliplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks Patients achieving stable disease partial response or regressive disease continue with therapy Patients achieving complete response for two consecutive evaluations receive an additional 2 courses of therapy Phase I closed as of 7500 Cohorts of 3-6 patients receive escalating doses of gemcitabine and oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Phase II Patients receive the MTD of gemcitabine and oxaliplatin as in phase I Patients are followed every 3 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 32-52 patients 12 patients to phase I phase I closed as of 7500 and 20-40 to phase II will be accrued for this study within approximately 11-28 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067431 | REGISTRY | PDQ Physician Data Query | None |