Clinical Study of Apatinib and XELOX Combination Regimen to Treat Colorectal Cancer Patients

NCT02829385 | Unknown Phase 2 DMC

• 1 other identifier: LZU-123
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study makes an observation over the objective response rate of Apatinib and XELOX combination regimen in the first-line treatment of metastatic colorectal cancer. All the participants will receive the treatment of Apatinib and XELOX combination regimen.

Conditions

Colorectal Neoplasms

Keywords

Apatinib; XELOX Regimen; metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR=complete response (CR) + partial response (PR) .And expected ORR is 0.55.

  up to 9 months

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  up to 2 years

• Overall Survival (OS)

  up to 2 years

Study Arms (1)

Apatinib combined treatment group

EXPERIMENTAL

Apatinib Mesylate Tablets 500 mg P.O.d1-21 and XELOX (oxaliplatin 130mg/㎡ i.v. d1, capecitabine 1000mg P.O. d1-d14) Every 3-week time is a cycle until PD or intolerance of drug toxicity occurs.

Drug: Apatinib and XELOX combined treatment group

Interventions

Apatinib and XELOX combined treatment group DRUG

Apatinib Mesylate Tablets 500 mg P.O.d1-21 and XELOX (oxaliplatin 130mg/㎡ i.v. d1, capecitabine 1000mg P.O. d1-d14) Every 3-week time is a cycle until PD or intolerance of drug toxicity occurs.

Also known as: Apatinib combined treatment group

Apatinib combined treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable colorectal cancer confirmed by histological means with measurable indication（a minimum size of 10mm by spiral CT scan，which meets the criteria of RECIST 1.1）.
• Time interval traced back to the latest administration of xelox and folfox combination must be no less than 1 year.
• age range: ≥18 and ≤75.
• ECOG PS scale 0 or 1；expected survival time ≥12 weeks.
• Sufficient blood function：absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥80×109/L and hemoglobin≥9g/dL.
• Sufficient hepatic function：total bilirubin ≤1.5 times upper normal limit(ULN), AST ≤2.5 times ULN, ALT ≤2.5 times ULN and AKP ≤5 times ULN.
• \*AST,ALT relevant criteria alters into AST ≤5 times ULN and ALT ≤5 times ULN if with hepatic metastasis.
• sufficient renal function: serum creatinin ≤ULN, creatinine clearance rate ≥60 mL/min
• Female patients under age 50 with complete uterus must be tested negative for pregnancy within 28 days before enrollment (except for those who suffered amenorrhea for more than 24 months). If the pregnancy test was carried out more than 7 days before the first administration, then the urine pregnancy test is required for validation. (within the 7-day interval before administration)
• Informed consent subscription. (The consent should be approved by independent Ethics Committee, and signed by patients before any substantial trial is initiated.)

You may not qualify if:

• Have got other malignant tumors within last 5 years, excluding basal cell skin cancer and cervical carcinoma in situ that has already been cured.
• With evidence of CNS metastasis, even if the treatment had been carried out before, patients with doubts of CNS metastasis should be conducted MRI or enhanced CT scan on within 28 days before enrollment for ruling out.
• AST ≤2.5 times ULN and/or ALT ≤2.5 times ULN
• Had been treated with chemotherapy for last 12 months
• Had been treated with radiotherapy (except for palliative radiotherapy with evaluable focus outside radiotherapy field on purpose of alleviating pains)
• With any uncontrolled systemic disease, including active infection, hypertension without treatment, diabetes mellitus, angina pectoris, congestive heart failure, myocardial infarction, severe arrhythmia requires treatment and hepatic/renal/metabolic diseases
• Taking experimental treatment from another clinical trial study.
• Being allergic to any relevant chemotherapy drug.
• With evidence-proved other diseases, neural or metabolic disorders, physical or lab examination abnormalities, which might be contraindication of study drugs or leading to treating-related lethal complications.

Sponsors & Collaborators

• Shoucheng Ma: lead

Study Sites (1)

Cancer Cnter,The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

RECRUITING

Related Publications (12)

• Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

  PMID: 26884585 RESULT

• Tabernero J, Van Cutsem E, Lakomy R, Prausova J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S, Allegra CJ. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014 Jan;50(2):320-31. doi: 10.1016/j.ejca.2013.09.013. Epub 2013 Oct 16.

  PMID: 24140268 RESULT

• Kara O, Duman BB, Kara B, Erdogan S, Parsak CK, Sakman G. Analysis of PTEN, VEGF, HER2 and P53 status in determining colorectal cancer benefit from bevacizumab therapy. Asian Pac J Cancer Prev. 2012;13(12):6397-401. doi: 10.7314/apjcp.2012.13.12.6397.

  PMID: 23464465 RESULT

• Custodio A, Barriuso J, de Castro J, Martinez-Marin V, Moreno V, Rodriguez-Salas N, Feliu J. Molecular markers to predict outcome to antiangiogenic therapies in colorectal cancer: current evidence and future perspectives. Cancer Treat Rev. 2013 Dec;39(8):908-24. doi: 10.1016/j.ctrv.2013.02.004. Epub 2013 Mar 16.

  PMID: 23510598 RESULT

• Bruera G, Cannita K, Giordano AV, Vicentini R, Ficorella C, Ricevuto E. Effectiveness and safety of intensive triplet chemotherapy plus bevacizumab, FIr-B/FOx, in young-elderly metastatic colorectal cancer patients. Biomed Res Int. 2013;2013:143273. doi: 10.1155/2013/143273. Epub 2013 Nov 6.

  PMID: 24307987 RESULT

• Sclafani F, Cunningham D. Bevacizumab in elderly patients with metastatic colorectal cancer. J Geriatr Oncol. 2014 Jan;5(1):78-88. doi: 10.1016/j.jgo.2013.08.006. Epub 2013 Sep 20.

  PMID: 24484722 RESULT

• Naeim A, Ward PR, Wang HJ, Dichmann R, Liem AK, Chan D, Patel R, Hu EH, Tchekmedyian NS, Wainberg ZA, Hecht JR. A phase II trial of frontline capecitabine and bevacizumab in poor performance status and/or elderly patients with metastatic colorectal cancer. J Geriatr Oncol. 2013 Oct;4(4):302-9. doi: 10.1016/j.jgo.2013.05.001. Epub 2013 Jun 7.

  PMID: 24472472 RESULT

• Simkens LH, van Tinteren H, May A, ten Tije AJ, Creemers GJ, Loosveld OJ, de Jongh FE, Erdkamp FL, Erjavec Z, van der Torren AM, Tol J, Braun HJ, Nieboer P, van der Hoeven JJ, Haasjes JG, Jansen RL, Wals J, Cats A, Derleyn VA, Honkoop AH, Mol L, Punt CJ, Koopman M. Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group. Lancet. 2015 May 9;385(9980):1843-52. doi: 10.1016/S0140-6736(14)62004-3. Epub 2015 Apr 7.

  PMID: 25862517 RESULT

• Kiss I, Bortlicek Z, Melichar B, Poprach A, Halamkova J, Vyzula R, Dusek L, Buchler T. Efficacy and toxicity of bevacizumab on combination with chemotherapy in different lines of treatment for metastatic colorectal carcinoma. Anticancer Res. 2014 Feb;34(2):949-54.

  PMID: 24511038 RESULT

• Kishiki T, Ohnishi H, Masaki T, Ohtsuka K, Ohkura Y, Furuse J, Watanabe T, Sugiyama M. Overexpression of MET is a new predictive marker for anti-EGFR therapy in metastatic colorectal cancer with wild-type KRAS. Cancer Chemother Pharmacol. 2014 Apr;73(4):749-57. doi: 10.1007/s00280-014-2401-4. Epub 2014 Feb 6.

  PMID: 24500024 RESULT

• Peeters M, Oliner KS, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, He P, Yu H, Koukakis R, Terwey JH, Jung AS, Sidhu R, Patterson SD. Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer. Clin Cancer Res. 2015 Dec 15;21(24):5469-79. doi: 10.1158/1078-0432.CCR-15-0526. Epub 2015 Sep 4.

  PMID: 26341920 RESULT

• Douillard JY, Oliner KS, Siena S, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocakova I, Ruff P, Blasinska-Morawiec M, Smakal M, Canon JL, Rother M, Williams R, Rong A, Wiezorek J, Sidhu R, Patterson SD. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013 Sep 12;369(11):1023-34. doi: 10.1056/NEJMoa1305275.

  PMID: 24024839 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Da Zhao, Bachelor

  Cancer Center of the First Hospital of Lanzhou University

  STUDY CHAIR

Central Study Contacts

Shoucheng Ma, Master

CONTACT

(86)13893453504; mashoucheng@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of cancer center

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 12, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2018
• Last Updated: July 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)