Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084643
Status:
COMPLETED
Last Update Posted:
2013-03-27
First Post:
2004-06-10
Brief Title:
GTI-2040 Oxaliplatin and Capecitabine in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer or Other Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of GTI-2040 in Combination With Oxaliplatin and Capecitabine in Patients With Advanced Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase I trial is studying the side effects and best dose of capecitabine when given together with GTI-2040 and oxaliplatin in treating patients with locally advanced or metastatic colorectal cancer or other solid tumors Drugs used in chemotherapy such as oxaliplatin and capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die GTI-2040 may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs Giving GTI-2040 together with oxaliplatin and capecitabine may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To establish the maximum tolerated MTD of a 21 day cycle of capecitabine given orally twice daily for 14 days in combination with oxaliplatin given intravenously on day 1 and GTI-2040 given as a continuous infusion over 14 days in patients with advanced metastatic solid tumors
II To describe the toxicities at each dose level studied
SECONDARY OBJECTIVES
I To evaluate the pharmacokinetics of GTI-2040 capecitabine and oxaliplatin when these are given in combination
II To evaluate levels of ribonucleotide reductase -M2 subunit RR-M2 mRNA levels using TaqMan RT-PCR in peripheral blood mononuclear cells and in tumor samples when available TRF support will be required and sought
III To quantitate changes in dCTP levels in peripheral blood mononuclear cells during treatment as a surrogate marker of RR inhibition TRF support will be required and sought
OUTLINE This is a multicenter dose-escalation study of capecitabine
Patients receive GTI-2040 IV continuously on days 1-14 oral capecitabine twice daily on days 2-15 and oxaliplatin IV over 2 hours on day 2 of the first course In all subsequent courses capecitabine is administered on days 1-14 oxaliplatin is administered on day 1 and GTI-2040 is administered as in course 1 Courses repeat every 21 days in the absence of disease progression and 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 preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
I To establish the maximum tolerated MTD of a 21 day cycle of capecitabine given orally twice daily for 14 days in combination with oxaliplatin given intravenously on day 1 and GTI-2040 given as a continuous infusion over 14 days in patients with advanced metastatic solid tumors
II To describe the toxicities at each dose level studied
SECONDARY OBJECTIVES
I To evaluate the pharmacokinetics of GTI-2040 capecitabine and oxaliplatin when these are given in combination
II To evaluate levels of ribonucleotide reductase -M2 subunit RR-M2 mRNA levels using TaqMan RT-PCR in peripheral blood mononuclear cells and in tumor samples when available TRF support will be required and sought
III To quantitate changes in dCTP levels in peripheral blood mononuclear cells during treatment as a surrogate marker of RR inhibition TRF support will be required and sought
OUTLINE This is a multicenter dose-escalation study of capecitabine
Patients receive GTI-2040 IV continuously on days 1-14 oral capecitabine twice daily on days 2-15 and oxaliplatin IV over 2 hours on day 2 of the first course In all subsequent courses capecitabine is administered on days 1-14 oxaliplatin is administered on day 1 and GTI-2040 is administered as in course 1 Courses repeat every 21 days in the absence of disease progression and 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 preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| CDR0000365466 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062505 |
| PHI-41 | None | None | None |
| U01CA062505 | NIH | None | None |