Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
"Apatinib" and "Capecitabine"
"Capecitabine"
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Apatinib, Capecitabine
Eligibility Criteria
Inclusion Criteria:
- Informed consent form should be issued prior to conducting any research process;
- Men or women aged 18-75 years;
- Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
- Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
- The estimated survival time is longer than 3 months;
- ECOG score was 0 or 1;
- According to the RECIST v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through CT or MRI(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress;
With sufficient organ and bone marrow function, defined as follows:
- Hb≥9 g/dL
- Absolute neutrophil count ≥1.0 × 109 /L
- Platelet count≥75 × 109 /L
- Serum bilirubin ≤ 1.5 × ULN, which would not be appropriate for patients with Gilbert syndrome (Persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin, with no evidence of hemolysis or abnormal liver pathology) which can consult a doctor
- ALT&AST ≤ 2.5 × ULN; for patients with liver metastases, ALT&AST ≤ 5 × ULN Calculate the creatinine clearance rate by Cockcroft-Gault formula
- Creatinine clearance rate measured( by actual body weight) or by measuring urine collection for 24 hours> 40 mL/min(the value of the measurement of the 24 - hour urine collection will be used to determine eligibility if the two methods are used)
- Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before inclusion, the results should be negative and they are willing to use the appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration. Men should agree to use appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration;
- Patients volunteered to participate in the trial and signed informed consent form with good compliance.
Exclusion Criteria:
- Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure >140 mmHg / diastolic pressure > 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men>450 ms, women >470 ms) and cardiac insufficiency;
- With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
- Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician;
- Abnormal coagulation function(INR>1.5×ULN、 APTT>1.5×ULN) with bleeding tendency;
- With Symptomatic central nervous system metastasis;
- Pregnant or lactating women;
- Other patients unsuitable for inclusion considered by the physician.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A: "apatinib" and "capecitabine"
B: "capecitabine" single drug
Arm Description
Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w
Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w
Outcomes
Primary Outcome Measures
Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged
Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03132025
Brief Title
Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
Official Title
Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2017 (Anticipated)
Primary Completion Date
February 28, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanqiao Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.
Detailed Description
To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer,primary endpoint include in mPFS; secondary endpoint include in mOS, tolerance and security.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer, Apatinib, Capecitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A: "apatinib" and "capecitabine"
Arm Type
Experimental
Arm Description
Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w
Arm Title
B: "capecitabine" single drug
Arm Type
Active Comparator
Arm Description
Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w
Intervention Type
Drug
Intervention Name(s)
"Apatinib" and "Capecitabine"
Other Intervention Name(s)
Arm A
Intervention Description
Combine "Apatinib" and "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer
Intervention Type
Drug
Intervention Name(s)
"Capecitabine"
Other Intervention Name(s)
Arm B
Intervention Description
Single Drug "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer
Primary Outcome Measure Information:
Title
Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged
Description
Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group
Time Frame
up to 10 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:
Informed consent form should be issued prior to conducting any research process;
Men or women aged 18-75 years;
Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
The estimated survival time is longer than 3 months;
ECOG score was 0 or 1;
According to the RECIST v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through CT or MRI(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress;
With sufficient organ and bone marrow function, defined as follows:
Hb≥9 g/dL
Absolute neutrophil count ≥1.0 × 109 /L
Platelet count≥75 × 109 /L
Serum bilirubin ≤ 1.5 × ULN, which would not be appropriate for patients with Gilbert syndrome (Persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin, with no evidence of hemolysis or abnormal liver pathology) which can consult a doctor
ALT&AST ≤ 2.5 × ULN; for patients with liver metastases, ALT&AST ≤ 5 × ULN Calculate the creatinine clearance rate by Cockcroft-Gault formula
Creatinine clearance rate measured( by actual body weight) or by measuring urine collection for 24 hours> 40 mL/min(the value of the measurement of the 24 - hour urine collection will be used to determine eligibility if the two methods are used)
Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before inclusion, the results should be negative and they are willing to use the appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration. Men should agree to use appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration;
Patients volunteered to participate in the trial and signed informed consent form with good compliance.
Exclusion Criteria:
Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure >140 mmHg / diastolic pressure > 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men>450 ms, women >470 ms) and cardiac insufficiency;
With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician;
Abnormal coagulation function(INR>1.5×ULN、 APTT>1.5×ULN) with bleeding tendency;
With Symptomatic central nervous system metastasis;
Pregnant or lactating women;
Other patients unsuitable for inclusion considered by the physician.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
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