Back to resultsA Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Raltitrexed
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility 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.
Sites / Locations
- Jiangsu Cancer Institute & HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Raltitrexed Plus Cetuximab
Arm Description
Raltitrexed Plus Cetuximab
Outcomes
Primary Outcome Measures
The time from the beginning of first-line treatment until the disease progresses.
Progression Free Survival 1.
The time from the beginning of maintenance treatment until the disease progresses.
Progression Free Survival 2.
Secondary Outcome Measures
Overall survival (OS)
Incidence of Treatment-Emergent Adverse Events Based on NCI-CTC 4.0
evaluate the safety of patient medication
Quality of life score
Based on QLQ-C30 in EORTC, evaluate the quality of life of patients
Full Information
NCT ID
NCT04241731
First Posted
January 23, 2020
Last Updated
August 27, 2021
Sponsor
Jiangsu Cancer Institute & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04241731
Brief Title
A Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer
Official Title
A Multicenter Phase II Clinical Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
November 28, 2021 (Anticipated)
Study Completion Date
November 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangsu Cancer Institute & Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Raltitrexed Plus Cetuximab
Arm Type
Experimental
Arm Description
Raltitrexed Plus Cetuximab
Intervention Type
Drug
Intervention Name(s)
Raltitrexed
Intervention Description
Raltitrexed 2.5mg / m2, intravenous infusion for 15min, d1,q2w.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab 500mg / kg, intravenous drip over 120min, d1,q2w.
Primary Outcome Measure Information:
Title
The time from the beginning of first-line treatment until the disease progresses.
Description
Progression Free Survival 1.
Time Frame
24 months
Title
The time from the beginning of maintenance treatment until the disease progresses.
Description
Progression Free Survival 2.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
24 months
Title
Incidence of Treatment-Emergent Adverse Events Based on NCI-CTC 4.0
Description
evaluate the safety of patient medication
Time Frame
24 months
Title
Quality of life score
Description
Based on QLQ-C30 in EORTC, evaluate the quality of life of patients
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liangjun Zhu
Phone
+8613905199123
Email
zhulj98@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng Li
Phone
+8613770768636
Email
lihsh198@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangjun Zhu
Organizational Affiliation
Jiangsu Cancer Institute & Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jiangsu Cancer Institute & Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangjun Zhu
Phone
+8613905199123
Email
zhulj98@foxmail.com
First Name & Middle Initial & Last Name & Degree
Sheng Li
Phone
+8613770768636
Email
lihsh198@163.com
12. IPD Sharing Statement
Learn more about this trial
A Study of Cetuximab Plus Raltitrexed for Maintenance Treatment in Advanced Colorectal Cancer
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