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Status unknownNCT01282658PSIFLUpdated Feb 17, 2011

Pharmacogenomics Study of CPT-11 as the First-line Chemotherapy for mCRC

An observational study in Colorectal Cancer, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-02-17.

Sponsored by Huazhong University of Science and Technology · Observational

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 75 Years
Sex
All
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Study summary

Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4 key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase, carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this study is to figure out the correlation between the genetic polymorphism and the drug response.

Read the detailed description

collect blood samples,determining genetic contribution to the safety and efficacy of CPT-11.

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Conditions studied

  • Colorectal Cancer

Keywords

  • CPT-11,pharmacogenomics,colorectal cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 200 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

primary care clinic

Inclusion criteria

  1. Histologically confirmed colorectal cancer
  2. ≥ 18 years old
  3. Measurable disease, defined as to RECIST criteria
  4. Unresectable metastatic disease OR First recurrence/metastasis after adjuvant therapy and not suitable for operation
  5. FOLFIRI±cetuximab/bevacizumab as the first-line therapy
  6. Without expected course of radiotherapy during the first-line chemotherapy
  7. No previous CPT-11 chemotherapy
  8. ECOG performance status (PS) 0-2
  9. Not pregnant or nursing and Negative pregnancy test
  10. Voluntarily signed the informed consent
  11. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  12. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present)
  13. Creatinine clearance > 50 mL/min OR serum creatinine ≤ 1.5 times ULN

Exclusion criteria

Exclusion Criteria:

  1. Brain metastases with obvious symptoms
  2. Severe bone marrow failure and can not be corrected
  3. Chronic diarrhea history
  4. Bowel obstruction without control
  5. Mental illness without control
  6. Clinically significant (i.e., active) cardiovascular disease, including any of the following: Cerebrovascular accidents/ Myocardial infarction/ Unstable angina/ New York Heart Association class II-IV congestive heart failure/ Serious cardiac arrhythmia requiring medication/ Uncontrolled hypertension
  7. Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix
  8. Pelvic radiotherapy for the past 1 year
  9. Known allergy to any of the components of the study medications
  10. Serious, nonhealing wound or ulcer
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Colorectal cancer
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Study locations

1 of 1 sites recruiting
  • Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology
    Wu han, Hubei 430030, China
    • Yuan x lin, PHD · Contact · yxl@medmail.com.cn · 0086-02783663342
    • Huang liu, MD · Contact · huangliu017@163.com · 0086-02783663514
    • Xie C hua, PHD · Sub investigator
    • Zhang Tao · Sub investigator
    Recruiting
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References and documents

Publications

  • Van Cutsem E, Nordlinger B, Adam R, Kohne CH, Pozzo C, Poston G, Ychou M, Rougier P; European Colorectal Metastases Treatment Group. Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer. 2006 Sep;42(14):2212-21. doi: 10.1016/j.ejca.2006.04.012. Epub 2006 Aug 10. PubMed 16904315 ↗
  • A Report of Cancer Incidence and Mortality from 34 Cancer Registries in China，2006. China Cancer 19:356-65, 2010
  • Yoo PS, Lopez-Soler RI, Longo WE, Cha CH. Liver resection for metastatic colorectal cancer in the age of neoadjuvant chemotherapy and bevacizumab. Clin Colorectal Cancer. 2006 Sep;6(3):202-7. doi: 10.3816/CCC.2006.n.036. PubMed 17026789 ↗
  • Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000 Sep 28;343(13):905-14. doi: 10.1056/NEJM200009283431302. PubMed 11006366 ↗
  • Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000 Mar 25;355(9209):1041-7. doi: 10.1016/s0140-6736(00)02034-1. Erratum In: Lancet 2000 Apr 15;355(9212):1372. PubMed 10744089 ↗
  • Rhodes KE, Zhang W, Yang D, Press OA, Gordon M, Vallbohmer D, Schultheis AM, Lurje G, Ladner RD, Fazzone W, Iqbal S, Lenz HJ. ABCB1, SLCO1B1 and UGT1A1 gene polymorphisms are associated with toxicity in metastatic colorectal cancer patients treated with first-line irinotecan. Drug Metab Lett. 2007 Jan;1(1):23-30. doi: 10.2174/187231207779814328. PubMed 19356014 ↗
  • Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, Karrison T, Janisch L, Ramirez J, Rudin CM, Vokes EE, Ratain MJ. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol. 2004 Apr 15;22(8):1382-8. doi: 10.1200/JCO.2004.07.173. Epub 2004 Mar 8. PubMed 15007088 ↗
  • Ramchandani RP, Wang Y, Booth BP, Ibrahim A, Johnson JR, Rahman A, Mehta M, Innocenti F, Ratain MJ, Gobburu JV. The role of SN-38 exposure, UGT1A1*28 polymorphism, and baseline bilirubin level in predicting severe irinotecan toxicity. J Clin Pharmacol. 2007 Jan;47(1):78-86. doi: 10.1177/0091270006295060. PubMed 17192505 ↗
  • Marcuello E, Altes A, Menoyo A, Del Rio E, Gomez-Pardo M, Baiget M. UGT1A1 gene variations and irinotecan treatment in patients with metastatic colorectal cancer. Br J Cancer. 2004 Aug 16;91(4):678-82. doi: 10.1038/sj.bjc.6602042. PubMed 15280927 ↗
  • Carlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, Rogatko A, Wang H, Blanchard RL. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res. 2005 Feb 1;11(3):1226-36. PubMed 15709193 ↗
  • Mathijssen RH, Marsh S, Karlsson MO, Xie R, Baker SD, Verweij J, Sparreboom A, McLeod HL. Irinotecan pathway genotype analysis to predict pharmacokinetics. Clin Cancer Res. 2003 Aug 15;9(9):3246-53. PubMed 12960109 ↗
  • Ando Y, Hasegawa Y. Clinical pharmacogenetics of irinotecan (CPT-11). Drug Metab Rev. 2005;37(3):565-74. doi: 10.1080/03602530500316254. PubMed 16257834 ↗
  • Paradiso A, Xu J, Mangia A, Chiriatti A, Simone G, Zito A, Montemurro S, Giuliani F, Maiello E, Colucci G. Topoisomerase-I, thymidylate synthase primary tumour expression and clinical efficacy of 5-FU/CPT-11 chemotherapy in advanced colorectal cancer patients. Int J Cancer. 2004 Aug 20;111(2):252-8. doi: 10.1002/ijc.20208. PubMed 15197779 ↗
  • Braun MS, Richman SD, Quirke P, Daly C, Adlard JW, Elliott F, Barrett JH, Selby P, Meade AM, Stephens RJ, Parmar MK, Seymour MT. Predictive biomarkers of chemotherapy efficacy in colorectal cancer: results from the UK MRC FOCUS trial. J Clin Oncol. 2008 Jun 1;26(16):2690-8. doi: 10.1200/JCO.2007.15.5580. Erratum In: J Clin Oncol. 2008 Sep 10;26(26):4363. PubMed 18509181 ↗
  • Smith NF, Figg WD, Sparreboom A. Pharmacogenetics of irinotecan metabolism and transport: an update. Toxicol In Vitro. 2006 Mar;20(2):163-75. doi: 10.1016/j.tiv.2005.06.045. Epub 2005 Nov 3. PubMed 16271446 ↗
  • Hoskins JM, Marcuello E, Altes A, Marsh S, Maxwell T, Van Booven DJ, Pare L, Culverhouse R, McLeod HL, Baiget M. Irinotecan pharmacogenetics: influence of pharmacodynamic genes. Clin Cancer Res. 2008 Mar 15;14(6):1788-96. doi: 10.1158/1078-0432.CCR-07-1472. PubMed 18347181 ↗
  • Yu Q, Zhang T, Xie C, Qiu H, Liu B, Huang L, Peng P, Feng J, Chen J, Zang A, Yuan X. UGT1A polymorphisms associated with worse outcome in colorectal cancer patients treated with irinotecan-based chemotherapy. Cancer Chemother Pharmacol. 2018 Jul;82(1):87-98. doi: 10.1007/s00280-018-3595-7. Epub 2018 May 4. PubMed 29728798 ↗
  • Li J, Yu Q, Fu S, Xu M, Zhang T, Xie C, Feng J, Chen J, Zang A, Cai Y, Fu Q, Liu S, Zhang M, Hong Q, Huang L, Yuan X. A novel genetic score model of UGT1A1 and TGFB pathway as predictor of severe irinotecan-related diarrhea in metastatic colorectal cancer patients. J Cancer Res Clin Oncol. 2016 Jul;142(7):1621-8. doi: 10.1007/s00432-016-2176-6. Epub 2016 May 9. PubMed 27160286 ↗
  • Huang L, Zhang T, Xie C, Liao X, Yu Q, Feng J, Ma H, Dai J, Li M, Chen J, Zang A, Wang Q, Ge S, Qin K, Cai J, Yuan X. SLCO1B1 and SLC19A1 gene variants and irinotecan-induced rapid response and survival: a prospective multicenter pharmacogenetics study of metastatic colorectal cancer. PLoS One. 2013 Oct 15;8(10):e77223. doi: 10.1371/journal.pone.0077223. eCollection 2013. PubMed 24143213 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01282658
Lead sponsor
Huazhong University of Science and Technology
Collaborators
Wuhan Union Hospital, China, Wuhan University
First posted
Jan 25, 2011
Start date
Nov 2010
Primary completion
Dec 2012 (estimated)
Completion
May 2013 (estimated)
Last update
Feb 17, 2011

Study contacts

Yuan X Lin, PHD
Contact
yxl@medmail.com.cn
0086-02783663342
huang liu, MD
Contact
huangliu017@163.com
0086-02783663514
Yuan X Lin, PHD
principal investigator · Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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