Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066781
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2003-08-06
Brief Title:
Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study Of Gemcitabine GEMZAR And Irinotecan CPT-11 In Previously Untreated Patients With Measurable Disease With Unknown Primary Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-02
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 such as gemcitabine and irinotecan 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 This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with cancer of unknown primary origin
PURPOSE This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with cancer of unknown primary origin
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with carcinoma of unknown primary when treated with gemcitabine and irinotecan
Determine the adverse event profile and tolerability of this regimen based on the presence or absence of the UGT1A128 polymorphism in these patients Cohort I closed to accrual 111705
Determine the adverse event profile and tolerability of this regimen Cohort II
Secondary
Determine the time to progression and overall survival of patients treated with this regimen
Correlate patterns of immunohistochemical staining with response in patients treated with this regimen
Correlate variation in multiple different genes whose protein products are involved in the uptake metabolism and distribution of these drugs with clinical outcomes in terms of response and toxicity in these patients
Determine primary origin of cancer of unknown primary samples by completing a 92-gene RT-PCR cancer classification assay
Determine whether the 92-gene assay results are correlated with clinical response to gemcitabine and irinotecan
OUTLINE
Cohort I closed to accrual 111705 Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 8 15 and 22 Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohort II Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 8 and 15 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
Primary
Determine the response rate in patients with carcinoma of unknown primary when treated with gemcitabine and irinotecan
Determine the adverse event profile and tolerability of this regimen based on the presence or absence of the UGT1A128 polymorphism in these patients Cohort I closed to accrual 111705
Determine the adverse event profile and tolerability of this regimen Cohort II
Secondary
Determine the time to progression and overall survival of patients treated with this regimen
Correlate patterns of immunohistochemical staining with response in patients treated with this regimen
Correlate variation in multiple different genes whose protein products are involved in the uptake metabolism and distribution of these drugs with clinical outcomes in terms of response and toxicity in these patients
Determine primary origin of cancer of unknown primary samples by completing a 92-gene RT-PCR cancer classification assay
Determine whether the 92-gene assay results are correlated with clinical response to gemcitabine and irinotecan
OUTLINE
Cohort I closed to accrual 111705 Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 8 15 and 22 Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohort II Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 8 and 15 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
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 |
|---|---|---|---|
| CDR0000318830 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2011-01592 | REGISTRY | None | None |