Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004090
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-12-10
Brief Title:
Gemcitabine and Cisplatin in Treating Patients With Metastatic or Recurrent Solid Tumors
Sponsor:
Northwestern University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Gemcitabine 10 mgm2Min and Cisplatin A Phase I Study
Status:
COMPLETED
Status Verified Date:
2011-01
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumors
PURPOSE Phase I trial to study the effectiveness of gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumors
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of gemcitabine and cisplatin in patients with metastatic or recurrent nonhematologic malignancies
OUTLINE This is a dose escalation study of gemcitabine Patients receive gemcitabine IV on days 1 and 8 followed immediately by cisplatin IV over 2 hours on day 8 Courses repeat every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 18 patients will be accrued for this study within 18 months
OUTLINE This is a dose escalation study of gemcitabine Patients receive gemcitabine IV on days 1 and 8 followed immediately by cisplatin IV over 2 hours on day 8 Courses repeat every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 18 patients will be accrued for this study within 18 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-G99-1581 | None | None | None |
| NU-CINJ98X1 | None | None | None |