Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010023
Status:
COMPLETED
Last Update Posted:
2011-04-05
First Post:
2001-02-02
Brief Title:
Capecitabine Combined With Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase I Study of Oral Fluoropyrimidine Capecitabine Xeloda Roche Combined With Intravenous Cisplatin in Patients With Advanced Cancer of the Digestive System
Status:
COMPLETED
Status Verified Date:
2011-04
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 chemotherapy drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of capecitabine combined with cisplatin in treating patients who have locally advanced or metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of capecitabine combined with cisplatin in treating patients who have locally advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES
Determine the dose-limiting toxicity maximum tolerated dose and the recommended phase II dose of capecitabine and cisplatin in patients with locally advanced or metastatic cancer of the upper gastrointestinal tract GI head and neck lung breast or carcinoma of unknown primary
Determine the toxic effects of this regimen in these patients
Evaluate possible antitumor effectiveness of this regimen in these patients
Determine the toxic effects of cisplatin and capecitabine at the recommended phase II dose in patients with cancer of the upper GI tract
Determine the overall survival time to progression and duration of response in patients treated with this regimen
OUTLINE This is a dose-escalation study of capecitabine
Patients receive oral capecitabine twice daily for 5 10 or 14 days Patients also receive cisplatin IV on day 1 of each course Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity DLT The recommended phase II dose is defined as the dose preceding the MTD provided no more than 3 of 12 patients experience DLT at that dose Twenty additional patients with cancer of the upper gastrointestinal tract receive treatment with cisplatin and capecitabine at the recommended phase II dose for at least 6 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 6 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 20-50 patients will be accrued for this study within 1-3 years
Determine the dose-limiting toxicity maximum tolerated dose and the recommended phase II dose of capecitabine and cisplatin in patients with locally advanced or metastatic cancer of the upper gastrointestinal tract GI head and neck lung breast or carcinoma of unknown primary
Determine the toxic effects of this regimen in these patients
Evaluate possible antitumor effectiveness of this regimen in these patients
Determine the toxic effects of cisplatin and capecitabine at the recommended phase II dose in patients with cancer of the upper GI tract
Determine the overall survival time to progression and duration of response in patients treated with this regimen
OUTLINE This is a dose-escalation study of capecitabine
Patients receive oral capecitabine twice daily for 5 10 or 14 days Patients also receive cisplatin IV on day 1 of each course Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity DLT The recommended phase II dose is defined as the dose preceding the MTD provided no more than 3 of 12 patients experience DLT at that dose Twenty additional patients with cancer of the upper gastrointestinal tract receive treatment with cisplatin and capecitabine at the recommended phase II dose for at least 6 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 6 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 20-50 patients will be accrued for this study within 1-3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016087 | NIH | None | None |
| NYU-9955 | None | None | None |
| ROCHE-NYU-9955 | None | None | None |
| NCI-G00-1908 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |