Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022646
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2001-08-10
Brief Title:
Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Clinical Trial Evaluating Three Schedules Of ALIMTA Plus Gemcitabine As Frontline Chemotherapy For Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
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 more than one drug and giving the drugs in different ways may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the tumor response rates in patients with locally advanced or metastatic non-small cell lung cancer treated with 3 different schedules of pemetrexed disodium and gemcitabine
Compare the duration of response time to progressive disease time to treatment failure and survival time in patients treated with these regimens
Compare the quantitative and qualitative toxic effects of these regimens in these patients
OUTLINE This is a randomized open-label study Patients are stratified according to stage of disease IIIB vs IV and ECOG performance status 0 vs 1 Patients are randomized to one of three treatment arms
Arm I Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1
Arm III Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8
Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive up to 6 additional courses of therapy
Patients are followed every 2 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 180 patients 60 per treatment arm will be accrued for this study within 20 months
Compare the tumor response rates in patients with locally advanced or metastatic non-small cell lung cancer treated with 3 different schedules of pemetrexed disodium and gemcitabine
Compare the duration of response time to progressive disease time to treatment failure and survival time in patients treated with these regimens
Compare the quantitative and qualitative toxic effects of these regimens in these patients
OUTLINE This is a randomized open-label study Patients are stratified according to stage of disease IIIB vs IV and ECOG performance status 0 vs 1 Patients are randomized to one of three treatment arms
Arm I Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1
Arm III Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8
Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive up to 6 additional courses of therapy
Patients are followed every 2 months for 1 year and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 180 patients 60 per treatment arm will be accrued for this study within 20 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 |
|---|---|---|---|
| CDR0000068838 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02399 | REGISTRY | None | None |