Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003747
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma
Sponsor:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Tumour Site Specific Study of Carboplatin and Temozolomide in Patients With Advanced Melanoma
Status:
UNKNOWN
Status Verified Date:
2001-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining carboplatin and temozolomide in treating patients who have unresectable or metastatic melanoma
PURPOSE Phase I trial to study the effectiveness of combining carboplatin and temozolomide in treating patients who have unresectable or metastatic melanoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of carboplatin and temozolomide in patients with unresectable or metastatic melanoma II Assess the safety of this cytotoxic combination in this patient population III Assess the preliminary evidence of efficacy of this combination in these patients
OUTLINE This is an open label dose escalation study Patients receive oral temozolomide once daily on days 1-5 Carboplatin IV is administered over 1 hour on day 1 Courses are repeated every 28 days Treatment continues for a maximum of 6 courses in the absence of toxicity and disease progression Sequential dose escalation of carboplatin with a fixed dose of temozolomide is followed by sequential dose escalation of carboplatin at a higher fixed dose of temozolomide Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxic effects If the combination treatment with carboplatin given on day 1 of temozolomide therapy is more toxic than anticipated then the study is repeated with carboplatin given on day 5 of temozolomide therapy Patients are followed at least every 2 months
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE This is an open label dose escalation study Patients receive oral temozolomide once daily on days 1-5 Carboplatin IV is administered over 1 hour on day 1 Courses are repeated every 28 days Treatment continues for a maximum of 6 courses in the absence of toxicity and disease progression Sequential dose escalation of carboplatin with a fixed dose of temozolomide is followed by sequential dose escalation of carboplatin at a higher fixed dose of temozolomide Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxic effects If the combination treatment with carboplatin given on day 1 of temozolomide therapy is more toxic than anticipated then the study is repeated with carboplatin given on day 5 of temozolomide therapy Patients are followed at least every 2 months
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-98069 | None | None | None |
| MTVERNHOSP-OCT1998 | None | None | None |