TS-1 in Combination With Calcium Folinate in Patients With Heavily Pre-treated mCRC
NCT ID: NCT03517618
Last Updated: 2018-05-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
41 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-07-05
Study Completion Date
2015-06-18
Brief Summary
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Primary Objective:
To determine disease control rate (DCR) of TS-1® in patients with heavily pre-treated metastatic colorectal cancer
Secondary Objectives:
* To determine objective response rate (ORR)
* To determine time to progression (TTP)
* To determine overall survival (OS)
* To assess incidence of adverse events (AEs), serious adverse events (SAEs) \[Safety and Tolerability\]
To determine disease control rate (DCR) of TS-1® in patients with heavily pre-treated metastatic colorectal cancer
Secondary Objectives:
* To determine objective response rate (ORR)
* To determine time to progression (TTP)
* To determine overall survival (OS)
* To assess incidence of adverse events (AEs), serious adverse events (SAEs) \[Safety and Tolerability\]
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Detailed Description
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Simon's optimal two-stage design will be used to determine the sample size for this study.
• Stage I: \>1/9: The first 9 evaluable patients enrolled, \>1 (or ≥2) responders are required in order to enter the second stage, otherwise the trial will be terminated at the first stage due to futility.
• Stage II: Total \>8/34: For the total 34 evaluable patients, \>8 (or ≥9) responders are required to conclude the effectiveness of the study regimen.
The primary endpoint will be disease control rate which will be presented in frequency tabulation with two-sided 95% confidence interval (using binomial estimation).
The secondary endpoints are described as follows:
* ORR will be presented in frequency tabulation with two-sided 95% confidence interval;
* TTP will be estimated by Kaplan-Meier method with two-sided 95% confidence interval;
* OS will be estimated by Kaplan-Meier method with two-sided 95% confidence interval;
* Incidence of adverse events (AEs), serious adverse events (SAEs) \[Safety and Tolerability\] : assessed by CTCAE v4.0. Safety parameters will only be analyzed on the safety analysis set and be presented in frequency tabulation.
• Stage I: \>1/9: The first 9 evaluable patients enrolled, \>1 (or ≥2) responders are required in order to enter the second stage, otherwise the trial will be terminated at the first stage due to futility.
• Stage II: Total \>8/34: For the total 34 evaluable patients, \>8 (or ≥9) responders are required to conclude the effectiveness of the study regimen.
The primary endpoint will be disease control rate which will be presented in frequency tabulation with two-sided 95% confidence interval (using binomial estimation).
The secondary endpoints are described as follows:
* ORR will be presented in frequency tabulation with two-sided 95% confidence interval;
* TTP will be estimated by Kaplan-Meier method with two-sided 95% confidence interval;
* OS will be estimated by Kaplan-Meier method with two-sided 95% confidence interval;
* Incidence of adverse events (AEs), serious adverse events (SAEs) \[Safety and Tolerability\] : assessed by CTCAE v4.0. Safety parameters will only be analyzed on the safety analysis set and be presented in frequency tabulation.
Conditions
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Metastatic Colorectal Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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S-1 + leucovorin
Single arm
Group Type
EXPERIMENTAL
S-1+leucovorin
Intervention Type
DRUG
Eligible patients will receive TS-1 orally 40-60 mg (depending on patient's body surface area (BSA)) in combination with calcium folinate 30 mg twice a day for 7 days in a 2-week cycle.
The treatment will be administered until disease progression, intolerable toxicity, or consent withdrawal during any time of the study.
Interventions
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S-1+leucovorin
Eligible patients will receive TS-1 orally 40-60 mg (depending on patient's body surface area (BSA)) in combination with calcium folinate 30 mg twice a day for 7 days in a 2-week cycle.
The treatment will be administered until disease progression, intolerable toxicity, or consent withdrawal during any time of the study.
Intervention Type
DRUG
Other Intervention Names
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TS-1+calcium folinate
Eligibility Criteria
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Inclusion Criteria
1. histologically or cytologically confirmed colorectal adenocarcinoma;
2. metastatic and unresectable disease;
3. presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of:
1. 10mm by CT scan and MRI (no less than double the slice thickness and a minimum of 10mm);
2. 20mm by conventional techniques;
4. previously treatment to
1. fluoropyrimidine, oxaliplatin and irinotecan;
2. at least one targeted therapy
5. adequate hematopoietic function which is defined as below:
1. hemoglobin ≥ 9 g/dL;
2. absolute neutrophil count (ANC) ≥ 1,500/mm3;
3. platelet count ≥ 100,000/mm3;
6. adequate hepatic function which is defined as below:
1. total bilirubin ≤ 2 times upper limit of normal (ULN);
2. hepatic transaminases (ALT and AST) ≤ 3 x ULN. If there are known liver metastases, ALT or AST must be ≤ 5 x ULN;
7. adequate renal function which is defined as below:
a. serum creatinine ≤ 1.5 x ULN;
8. age of 20 years or above;
9. ECOG performance status 0-2;
10. life expectancy of at least 12 weeks;
11. ability to take oral medication;
12. ability to understand and willingness to sign a written informed consent document.
2. metastatic and unresectable disease;
3. presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of:
1. 10mm by CT scan and MRI (no less than double the slice thickness and a minimum of 10mm);
2. 20mm by conventional techniques;
4. previously treatment to
1. fluoropyrimidine, oxaliplatin and irinotecan;
2. at least one targeted therapy
5. adequate hematopoietic function which is defined as below:
1. hemoglobin ≥ 9 g/dL;
2. absolute neutrophil count (ANC) ≥ 1,500/mm3;
3. platelet count ≥ 100,000/mm3;
6. adequate hepatic function which is defined as below:
1. total bilirubin ≤ 2 times upper limit of normal (ULN);
2. hepatic transaminases (ALT and AST) ≤ 3 x ULN. If there are known liver metastases, ALT or AST must be ≤ 5 x ULN;
7. adequate renal function which is defined as below:
a. serum creatinine ≤ 1.5 x ULN;
8. age of 20 years or above;
9. ECOG performance status 0-2;
10. life expectancy of at least 12 weeks;
11. ability to take oral medication;
12. ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria
1. history or known presence of brain metastasis;
2. presence of mental disease or psychotic manifestation;
3. significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
4. presence of diarrhea ≥ grade 2 in common terminology criteria for adverse event version 4.0 (CTCAE v4.0);
5. other malignancy within the past 5 years (different site or histology) except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
6. recent (within 30 days prior to study treatment) treatment of another investigational drug;
7. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential should have effective contraception for both the patient and his or her partner during the study.
2. presence of mental disease or psychotic manifestation;
3. significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
4. presence of diarrhea ≥ grade 2 in common terminology criteria for adverse event version 4.0 (CTCAE v4.0);
5. other malignancy within the past 5 years (different site or histology) except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
6. recent (within 30 days prior to study treatment) treatment of another investigational drug;
7. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential should have effective contraception for both the patient and his or her partner during the study.
Minimum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Sponsor Role
collaborator
TTY Biopharm
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hung-Chih Hsu
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital, Linkou, Taiwan
Locations
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Chang-Gung Memorial Hospital, Linkou
Linkou District, , Taiwan
Site Status
Countries
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Taiwan
References
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Other Identifiers
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TG1307
Identifier Type: -
Identifier Source: org_study_id
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