Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040885
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2002-07-08
Brief Title:
Docetaxel With or Without Infliximab in Treating Weight Loss Loss of Appetite and Fatigue in Patients With Unresectable Non-Small Cell Lung Cancer Infliximab Treatment Discontinued Effective 100505
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Docetaxel And InfliximabPlacebo In Non-Small Cell Lung Cancer NSCLC Patients Greater Than Or Equal To 65 Years Of Age Or In NSCLC Patients With Poor Performance Status A Double-Blind Randomized Placebo-Controlled Trial To Prevent And Treat Wasting Anorexia And Asthenia In Chemotherapy-Naive And Previously-Treated Patients
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 such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Infliximab may improve cancer-related weight loss lack of appetite and fatigue It is not yet known whether docetaxel is more effective with or without infliximab in preventing weight loss and fatigue in patients with advanced cancer Infliximab treatment discontinued effective 100505
PURPOSE Randomized phase III trial to determine the effectiveness of docetaxel with or without infliximab in preventing weight loss loss of appetite and fatigue in patients who have unresectable non-small cell lung cancer Infliximab treatment discontinued effective 100505
PURPOSE Randomized phase III trial to determine the effectiveness of docetaxel with or without infliximab in preventing weight loss loss of appetite and fatigue in patients who have unresectable non-small cell lung cancer Infliximab treatment discontinued effective 100505
Detailed Description:
OBJECTIVES
Compare the improvement or stabilization of weight in elderly or poor performance status patients with unresectable non-small cell lung cancer treated with docetaxel with or without infliximab infliximab treatment discontinued effective 100505
Compare appetite and functional status in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the augmentation or maintenance of lean tissue in patients treated with these regimens
Compare the response rates and time to disease progression in patients treated with these regimens
Compare the survival of patients treated with these regimens
Determine whether the tumor necrosis factor-alpha polymorphisms in the -308 and -238 regions predict which cancer patients will experience loss of appetite and weight and which patients might potentially benefit from infliximab infliximab treatment discontinued effective 100505
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to weight loss within the past 6 months 0 vs more than 0 to less than 5 vs at least 5 number of prior chemotherapy regimens 0 vs 1 vs more than 1 gender and GBU prognostic index good vs bad vs unsure
Part A non-randomized single-center portion of study Five patients receive infliximab IV infliximab treatment discontinued effective 100505 over 2 hours once weekly on weeks 1 3 and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour immediately after completion of infliximab infusion infliximab treatment discontinued effective 100505 once weekly on weeks 1-6 of each course Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity
If none of the 5 patients experiences any grade 4 or 5 toxicity directly attributable to infliximab infliximab treatment discontinued effective 100505 additional patients are accrued for part B of the study
Part B randomized multicenter portion of study Patients are randomized to 1 of 2 treatment arms
Arm I infliximab treatment discontinued effective 100505 Patients receive infliximab and docetaxel as in part A
Arm II Patients receive docetaxel as in part A and placebo IV over 2 hours according to the infliximab schedule in part A infliximab treatment discontinued effective 100505
Treatment in both arms repeats as in part A
Quality of life fatigue appetiteanorexia cachexia and weight are assessed at baseline weekly on weeks 1-8 and then monthly for the remainder of study treatment
Patients are followed every 6 months for 5 years
Compare the improvement or stabilization of weight in elderly or poor performance status patients with unresectable non-small cell lung cancer treated with docetaxel with or without infliximab infliximab treatment discontinued effective 100505
Compare appetite and functional status in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the augmentation or maintenance of lean tissue in patients treated with these regimens
Compare the response rates and time to disease progression in patients treated with these regimens
Compare the survival of patients treated with these regimens
Determine whether the tumor necrosis factor-alpha polymorphisms in the -308 and -238 regions predict which cancer patients will experience loss of appetite and weight and which patients might potentially benefit from infliximab infliximab treatment discontinued effective 100505
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to weight loss within the past 6 months 0 vs more than 0 to less than 5 vs at least 5 number of prior chemotherapy regimens 0 vs 1 vs more than 1 gender and GBU prognostic index good vs bad vs unsure
Part A non-randomized single-center portion of study Five patients receive infliximab IV infliximab treatment discontinued effective 100505 over 2 hours once weekly on weeks 1 3 and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour immediately after completion of infliximab infusion infliximab treatment discontinued effective 100505 once weekly on weeks 1-6 of each course Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity
If none of the 5 patients experiences any grade 4 or 5 toxicity directly attributable to infliximab infliximab treatment discontinued effective 100505 additional patients are accrued for part B of the study
Part B randomized multicenter portion of study Patients are randomized to 1 of 2 treatment arms
Arm I infliximab treatment discontinued effective 100505 Patients receive infliximab and docetaxel as in part A
Arm II Patients receive docetaxel as in part A and placebo IV over 2 hours according to the infliximab schedule in part A infliximab treatment discontinued effective 100505
Treatment in both arms repeats as in part A
Quality of life fatigue appetiteanorexia cachexia and weight are assessed at baseline weekly on weeks 1-8 and then monthly for the remainder of study treatment
Patients are followed every 6 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 |
|---|---|---|---|
| CDR0000069417 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02472 | REGISTRY | None | None |
| NCI-P02-0226 | None | None | None |