Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003970
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
1999-11-01
Brief Title:
Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Clinical Trial to Investigate the Correlation Between UGT1A1 Genotype and Irinotecan CPT-11 Pharmacokinetics and Toxicity in Cancer Patients
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:
Phase I trial to study genetic testing and the effectiveness of irinotecan in treating patients who have solid tumors and lymphoma Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a persons genetic makeup
Detailed Description:
OBJECTIVES
I Classify patients with solid tumors or lymphoma according to UGT1A1 promoter TATA box and coding region Gly71Arg mutation and CYP3A4 promoter G to A polymorphisms
II Identify UGT1A1 enzyme glucuronidator and irinotecan oxidizer phenotypes in these patients and determine the correlation between the two metabolic reactions in vivo
III Determine the relationship between UGT1A1 genotype promoter andor coding region mutation and CYP3A4 promoter genotype vs gastrointestinal or bone marrow toxicity and pharmacokinetics of irinotecan in these patients
IV Determine the pharmacokinetics of irinotecan in these patients
OUTLINE Patients are genotyped for UGT1A1 enzyme and classified as Gilberts 77 heterozygotes 67 and homozygotes for allele 6 66 The DNA is analyzed for the UGT1A1 coding region mutation Gly71Arg and CYP3A4 promoter polymorphism Patients are also examined for glucuronidator ratio of SN-38 the active metabolite of irinotecan and classified as lowslow very low or zero SN-38GSN-38 ratio intermediate less than 50 normal ratio or normal
Patients receive irinotecan IV over 90 minutes once every 3 weeks Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity
I Classify patients with solid tumors or lymphoma according to UGT1A1 promoter TATA box and coding region Gly71Arg mutation and CYP3A4 promoter G to A polymorphisms
II Identify UGT1A1 enzyme glucuronidator and irinotecan oxidizer phenotypes in these patients and determine the correlation between the two metabolic reactions in vivo
III Determine the relationship between UGT1A1 genotype promoter andor coding region mutation and CYP3A4 promoter genotype vs gastrointestinal or bone marrow toxicity and pharmacokinetics of irinotecan in these patients
IV Determine the pharmacokinetics of irinotecan in these patients
OUTLINE Patients are genotyped for UGT1A1 enzyme and classified as Gilberts 77 heterozygotes 67 and homozygotes for allele 6 66 The DNA is analyzed for the UGT1A1 coding region mutation Gly71Arg and CYP3A4 promoter polymorphism Patients are also examined for glucuronidator ratio of SN-38 the active metabolite of irinotecan and classified as lowslow very low or zero SN-38GSN-38 ratio intermediate less than 50 normal ratio or normal
Patients receive irinotecan IV over 90 minutes once every 3 weeks Treatment continues for at least 2 courses in the absence of disease progression or unacceptable 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 |
|---|---|---|---|
| CDR0000067173 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA069852 |
| 9531 | None | None | None |
| U01CA069852 | NIH | None | None |