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A Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03344614
Recruitment Status : Unknown
Verified October 2017 by Dai, Guanghai, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Dai, Guanghai, Chinese PLA General Hospital

Study Description
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Brief Summary:
30 patients with advanced colorectal cancer will be enrolled to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: raltitrexed combined with apatinib Phase 2

Detailed Description:
In this study, we plan to enroll 30 patients with advanced colorectal cancer after failure of second-line standard chemotherapy. The therapeutic regimen is raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, qd,po, d1-21, Every 3 weeks for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. Aim to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment of in patients with advanced colorectal cancer.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Single Arm Exploratory Study of Apatinib Mesylate Tablets in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : July 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: raltitrexed combined with apatinib
therapeutic regimen : raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles.
 Drug: raltitrexed combined with apatinib
raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: 6 months ]
    Progression-free survival progression-free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: 12 months ]
    overall survival

  2. ORR [ Time Frame: 12 months ]
    Objective Response Rate

  3. DCR [ Time Frame: 12 months ]
    Disease Control Rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Male or female, ≥ 18 of age;
  • 2.Histological confirmed advanced colorectal adenocarcinoma，and at least one measurable lesion;
  • 3.Have failed for ≥ 2 lines of standard chemotherapy(included Fluorouracil, irinotecan and oxaliplatin);
  • 4.ECOG performance status 0-2;
  • 5.Life expectancy of more than 3 months;

  • 6.The main organs function is well, and randomized within 14 days before the relevant inspection indicators to meet the following requirements:

    1. blood routine test Hgb ﹥90g/L, ANC﹥1.5×109/L, Platelets ﹥ 100×109/L,
    2. biochemical tests Serum Total bilirubin ≤ 1.5 X UNL(upper normal limit), ALT or AST ≤ 2 xUNL, and ﹤ 5 x UNL（Hematogenous metastases）, Creatinine clearance rate≥ 60 ml/min(Cockcroft-Gault formula),
    3. Doppler echocardiography assessment：LVEF ≥ 50%;
  • 7.No serious heart, lung, liver, kidney dysfunction; no jaundice and gastrointestinal obstruction; no acute infection;
  • 8.Signed informed consent;
  • 9.Good compliance, and family members agree to receive survival follow-up.

Exclusion Criteria:

  • 1.Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344614


Contacts
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Contact: Haiyan Si, M.D. +8613911070673 sihaiyan2008@sina.com
Contact: Guanghai Dai, M.D. +8613801232381 daigh301@vip.sina.com

Locations
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China, Beijing
Chinese PLA General Hospital (301 Military Hospital) Recruiting
Beijing, Beijing, China, 100853
Contact: Haiyan Si, M.D.    +8613911070673    sihaiyan2008@sina.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Haiyan Si, M.D. Chinese PLA General Hospital (301 Military Hospital)
More Information
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Responsible Party: Dai, Guanghai, Department Director,M.D., Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03344614    
Other Study ID Numbers: AHEAD-311
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dai, Guanghai, Chinese PLA General Hospital:
third-line treatment
apatinib
raltitrexed
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Apatinib
Raltitrexed
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Folic Acid Antagonists