Trial Outcomes & Findings for Exploratory Study Of The ERCC-1 Gene (NCT NCT00846482)

Results Overview

ERCC was measured at the expression level, by RT-PCR and Western Blotting from peripheral blood mononuclear cells

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

Change over 1 treatment cycle, up to 4 weeks

Results posted on

2020-09-16

Participant milestones
Measure	Resected or Metastatic CRC All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks
Overall Study STARTED	64
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	10

Withdrawal data not reported

Exploratory Study Of The ERCC-1 Gene

Baseline characteristics by cohort
Measure	Resected or Metastatic CRC n=54 Participants All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants
Race/Ethnicity, Customized Black	14 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	26 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Unkown	2 Participants n=5 Participants

Timeframe: Change over 1 treatment cycle, up to 4 weeks

Population: Any patient with CRC who received oxaliplatin

ERCC was measured at the expression level, by RT-PCR and Western Blotting from peripheral blood mononuclear cells

Outcome measures
Measure	All Patients With CRC n=50 Participants All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin	25 Participants

Timeframe: Change over 1 treatment cycle, up to 4 weeks

Outcome measures
Measure	All Patients With CRC n=50 Participants All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin Oxaliplatin: Oxaliplatin will be administered once every 2 or 3 weeks
Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level CC genotype	22 participants
Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level C/T genotype	21 participants
Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level TT genotype	7 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Montefiore Medical Center

Phone: 718-405-8404