Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005636
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-02
Brief Title:
Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Single-Blind Randomized Phase III Trial of MTA Plus Cisplatin Versus Cisplatin in Patients With Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2013-06
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 It is not yet known if cisplatin is more effective with or without pemetrexed disodium for malignant mesothelioma of the pleura
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin with or without pemetrexed disodium in treating patients who have malignant mesothelioma of the pleura that cannot be removed by surgery
PURPOSE Randomized phase III trial to compare the effectiveness of cisplatin with or without pemetrexed disodium in treating patients who have malignant mesothelioma of the pleura that cannot be removed by surgery
Detailed Description:
OBJECTIVES I Compare survival in patients with malignant pleural mesothelioma when treated with cisplatin with or without LY231514 II Compare duration of response time to progression and time to treatment failure in these patients with these treatment regimens III Compare tumor response rate and clinical benefit of these treatment regimens in these patients IV Compare Lung Cancer Symptom Scale scores pulmonary function test scores and lung density determinations with these treatment regimens in these patients V Compare toxicity of these treatment regimens in these patients VI Assess pharmacokinetics and vitamin metabolite status with these treatment regimens in these patients
OUTLINE This is a randomized single blind multicenter study Patients are stratified according to performance status Karnofsky 70-80 vs 90-100 degree of measurability bidimensional vs unidimensional only histologic subtype epithelial vs all others WBC 8300mm3 and higher vs less than 8300mm3 pain intensity low vs high analgesic consumption low vs high dyspnea low vs high homocysteine low vs high gender country and treatment center Patients are randomized to one of two treatment arms Arm I Patients receive LY231514 IV over 10 minutes followed by cisplatin IV over 2 hours on day 1 Arm II Patients receive cisplatin as in arm I Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study within 15 months
OUTLINE This is a randomized single blind multicenter study Patients are stratified according to performance status Karnofsky 70-80 vs 90-100 degree of measurability bidimensional vs unidimensional only histologic subtype epithelial vs all others WBC 8300mm3 and higher vs less than 8300mm3 pain intensity low vs high analgesic consumption low vs high dyspnea low vs high homocysteine low vs high gender country and treatment center Patients are randomized to one of two treatment arms Arm I Patients receive LY231514 IV over 10 minutes followed by cisplatin IV over 2 hours on day 1 Arm II Patients receive cisplatin as in arm I Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study within 15 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 |
|---|---|---|---|
| NCI-G00-1767 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067791 | REGISTRY | None | None |
| CWRU-LILY-1599 | None | None | None |
| LILLY-H3E-MC-JMCHa | None | None | None |