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A Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241731
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Liangjun Zhu M.M., Jiangsu Cancer Institute & Hospital

Brief Summary:
Maintenance treatment can extend patient survival and improve patient quality of life. Bevacizumab alone or capecitabine combined with bevacizumab as a maintenance treatment have been widely used in clinical practice. In contrast, there are little datas of cetuximab as a maintenance treatment. The purpose of this study is to evaluate efficacy and safety of Raltitrexed plus Cetuximab as the maintenance treatment, and to provide a new choice for RAS wild-type colorectal cancer patients after advanced first-line chemotherapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Raltitrexed Drug: Cetuximab Phase 2

Detailed Description:
Maintenance treatment can prevent the toxicity and give patients a relative buffer period to alleviate the impact of follow-up treatment on the body without reducing efficacy. Bevacizumab alone or capecitabine combined with bevacizumab as a maintenance treatment have been widely used in clinical practice. There are little datas of cetuximab as a maintenance treatment ,some studies show that Cetuximab is effective in maintenance treatment, and some studies have reported adverse effects of Capecitabine combined with Cetuximab.So it is worthwhile to explore more suitable maintenance treatment options. Raltitrexed, a TS enzyme inhibitor, is an effective chemotherapy drug for colorectal cancer. We plan to evaluate efficacy and safety of Raltitrexed plus Cetuximab in maintenance treatment. Maybe we can provide a new choice for RAS wild-type colorectal cancer patients after advanced first-line chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Clinical Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer
Actual Study Start Date : November 28, 2019
Estimated Primary Completion Date : November 28, 2021
Estimated Study Completion Date : November 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Raltitrexed Plus Cetuximab
Raltitrexed Plus Cetuximab
Drug: Raltitrexed
Raltitrexed 2.5mg / m2, intravenous infusion for 15min, d1,q2w.

Drug: Cetuximab
Cetuximab 500mg / kg, intravenous drip over 120min, d1,q2w.




Primary Outcome Measures :
  1. The time from the beginning of first-line treatment until the disease progresses. [ Time Frame: 24 months ]
    Progression Free Survival 1.

  2. The time from the beginning of maintenance treatment until the disease progresses. [ Time Frame: 24 months ]
    Progression Free Survival 2.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 24 months ]
  2. Incidence of Treatment-Emergent Adverse Events Based on NCI-CTC 4.0 [ Time Frame: 24 months ]
    evaluate the safety of patient medication

  3. Quality of life score [ Time Frame: 24 months ]
    Based on QLQ-C30 in EORTC, evaluate the quality of life of patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-75 years old, no gender restriction;
  • RAS wild-type
  • Unresectable metastatic colorectal cancer confirmed by histopathology and / or cytology;
  • Disease stable or improved while on first-line use of FOLFOX/FOLFIRI with cetuximab for 4-6 months;
  • At least one measurable objective tumor lesion by spiral CT scan,the longest diameter measured ≧ 10 mm,or by conventional CT scan,the diameter measured ≧ 20 mm.
  • Eastern Cooperative Oncology Group (ECOG) general status score is 0-2;
  • Life expectancy of at least 3 months;
  • Blood routine, liver and kidney function within the 7 days before screening meet the following criteria: Absolute neutrophil count ≥ 1.5x10^9 / L; hemoglobin ≥ 9.0 g / dl; platelet count ≥ 80 x10^9 / L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN (≤5 x ULN in patients with liver metastases); ≤3 x ULN in patients with liver metastases (≤5 x ULN in patients with liver metastases); serum creatinine ≤1.5 x ULN;
  • Agree to sign informed consent.

Exclusion Criteria:

  • BRAF mutant
  • Symptomatic brain or meningeal metastases (unless patients receive treatment> 6 months, imaging results are negative within 4 weeks before joining the study, and tumor-related clinical symptoms are stable before joining the study);
  • Previous malignant disease within five years, with the exception of the cured primary cervical cancer or basal cell carcinoma of the skin;
  • Chronic intestinal disease, infectious intestinal disease, intestinal obstruction, active clinical severe infection and other diseases;
  • With ascites
  • Substance abuse and medical, psychological or social conditions that may interfere with the participation of patients in the study or influence the evaluation of the results of the study;
  • Unsuitable for the study or other chemotherapy determined by investigator.

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): NCT04241731


Contacts
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Contact: Liangjun Zhu +8613905199123 zhulj98@foxmail.com
Contact: Sheng Li +8613770768636 lihsh198@163.com

Locations
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China, Jiangsu
Jiangsu Cancer Institute & Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Liangjun Zhu    +8613905199123    zhulj98@foxmail.com   
Contact: Sheng Li    +8613770768636    lihsh198@163.com   
Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Investigators
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Study Chair: Liangjun Zhu Jiangsu Cancer Institute & Hospital
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Responsible Party: Liangjun Zhu M.M., Ward Director of Internal Medicine, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier: NCT04241731    
Other Study ID Numbers: JS-GI1901
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Cetuximab
Raltitrexed
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Enzyme Inhibitors