Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016952
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2001-06-06
Brief Title:
Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study in Patients With Metastatic Colorectal Carcinoma Previously Treated With Oxaliplatin OXAL or a Combination of Irinotecan CPT-11 and OXAL
Status:
COMPLETED
Status Verified Date:
2016-12
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 Giving the drugs in different combinations may kill more tumor cells
PURPOSE Phase II trial to compare the effectiveness of either irinotecan or fluorouracil plus leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with oxaliplatin with or without irinotecan
PURPOSE Phase II trial to compare the effectiveness of either irinotecan or fluorouracil plus leucovorin in treating patients who have metastatic colorectal cancer that has been previously treated with oxaliplatin with or without irinotecan
Detailed Description:
OBJECTIVES
Determine the tumor response rate in patients receiving irinotecan or fluorouracil and leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin with or without irinotecan
Determine the time to tumor progression time to treatment failure and overall survival of patients treated with these regimens
Determine the toxic effects of these regimens in these patients
Evaluate the quality of life of patients treated with these regimens
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy Patients are assigned to one of two treatment groups
Group I prior oxaliplatin-based chemotherapy Patients receive irinotecan IV over 90 minutes on day 1 Treatment repeats every 3 weeks
Group II prior irinotecan and oxaliplatin combination chemotherapy Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2 Treatment repeats every 2 weeks
Both groups Treatment continues in the absence of disease progression or unacceptable toxicity Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigators discretion
Quality of life is assessed at baseline approximately every 6 weeks during treatment and then after the last course of treatment
Patients are followed every 3 months for 5 years
Determine the tumor response rate in patients receiving irinotecan or fluorouracil and leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin with or without irinotecan
Determine the time to tumor progression time to treatment failure and overall survival of patients treated with these regimens
Determine the toxic effects of these regimens in these patients
Evaluate the quality of life of patients treated with these regimens
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy Patients are assigned to one of two treatment groups
Group I prior oxaliplatin-based chemotherapy Patients receive irinotecan IV over 90 minutes on day 1 Treatment repeats every 3 weeks
Group II prior irinotecan and oxaliplatin combination chemotherapy Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2 Treatment repeats every 2 weeks
Both groups Treatment continues in the absence of disease progression or unacceptable toxicity Patients with a confirmed complete response for 2 consecutive courses may discontinue treatment at investigators discretion
Quality of life is assessed at baseline approximately every 6 weeks during treatment and then after the last course of treatment
Patients are followed every 3 months for 5 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 |
|---|---|---|---|
| CDR0000068635 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02383 | REGISTRY | None | None |