Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330746
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
2006-05-26
Brief Title:
CALC-1 Cetuximab in Advanced Lung Cancer Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy
Status:
COMPLETED
Status Verified Date:
2012-05
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:
CALC-1
Brief Summary:
The purpose of this study is to select the more promising method of combining cetuximab with gemcitabine for treating patients with advanced non small-cell lung cancer who are not candidates for platinum based therapy
Detailed Description:
The standard treatment for advanced non small cell lung cancer NSCLC is combination chemotherapy with cisplatin or carboplatin Due to its toxicity this therapy may not be suited for certain patients including the elderly those whose general condition is poor Combining chemotherapy with a biologic agent targeted therapy is a new strategy being evaluated for the treatment of NSCLC and cetuximab is one of the drugs that has shown promise for its activity and tolerability This study aims to determine the more promising of 2 methods of combining gemcitabine with cetuximab in combination vs sequential administration in two groups of patients who are not candidates for combination platinum based chemotherapy patients under age 70 with performance status 2 expected enrollment 42 and patients over age 70 expected enrollment 58
Patients will be randomly assigned to one of two treatment arms
Arm A Cetuximab Gemcitabine
Cetuximab given intravenously weekly AND
Gemcitabine given intravenously for a maximum of 6 cycles on days 1 and 8 of each 3 week cycle
Arm B Gemcitabine followed by Cetuximab
Gemcitabine given intravenously for a maximum of 6 cycles on days 1 and 8 of each 3 week cycle THEN
Cetuximab given intravenously weekly
In Arm B Cetuximab is administered as maintenance therapy when there has been an objective response to chemotherapy or as second line therapy in patients who had disease progression during chemotherapy
Patients will be randomly assigned to one of two treatment arms
Arm A Cetuximab Gemcitabine
Cetuximab given intravenously weekly AND
Gemcitabine given intravenously for a maximum of 6 cycles on days 1 and 8 of each 3 week cycle
Arm B Gemcitabine followed by Cetuximab
Gemcitabine given intravenously for a maximum of 6 cycles on days 1 and 8 of each 3 week cycle THEN
Cetuximab given intravenously weekly
In Arm B Cetuximab is administered as maintenance therapy when there has been an objective response to chemotherapy or as second line therapy in patients who had disease progression during chemotherapy
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 |
|---|---|---|---|
| 2004-002811-98 | EUDRACT_NUMBER | None | None |