Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients
Primary Purpose
Clinical Response, Toxicity, Survival
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
metronomic XELOX
Classic XELOX
Blood samples for pharmacological studies
Sponsored by
About this trial
This is an interventional other trial for Clinical Response focused on measuring colorectal cancer, metronomic capecitabine
Eligibility Criteria
Inclusion Criteria:
- Patient age 18-70 years of both sexes.
- PS 0-2 and histologically proven mCRC with unresectable metastases (rectal cancer is included to left side cancers).
- They should have measurable lesions (that can be accurately measured in at least one dimension using calipers or ruler and measurement must be at least 20 mm using conventional techniques or 10 mm using spiral CT scan).
- No previous treatment for metastatic disease and had ended adjuvant treatment > 6 months.
- peripheral neuritis less than grade 2.
- Normal organ functions:(Creatinine ≤1.2, Bilirubin ≤1.2, SGOT/SGPT< 2N, HB >9gm/dl, WBC>3.5/dl with ANC >1.5/dl, Plat ≥100/dl).
- For patients with liver metastases, Bilirubin should not be >2.5N and transaminases not >5N. (All patients were screened for HCV and HBS Ag by PCR).
- Adequate cardiac functions (EF>55%)
Exclusion Criteria:
- patients with only ascites or bone metastasis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Classic (A)
metronomic (B)
Arm Description
patients recieving classic XELOX (oxaliplatin 130mg/m2 and capecitabine 1000mg/m2 bid)
patients recieving low dose capecitabine (2000mg daily divided in two doses for 8 weeks) and oxaliplatin (30mg/m2 weekly for eight weeks) followed by 2 weeks rest.
Outcomes
Primary Outcome Measures
response rates
Calculated with 95% confidence interval
Rate of toxicities and grades
Categorical data summarized by pecentages
Peak and trough levels of capecitabine and relation to dosing
Numerical data summarized by means and standard deviation
Secondary Outcome Measures
Progression free survival
Cox proportional hazard model
Overall survival
Kaplan and Meier test
Full Information
NCT ID
NCT04425564
First Posted
June 2, 2020
Last Updated
June 6, 2020
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04425564
Brief Title
Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients
Official Title
Clinico-pharmacological Study of Metronomic Capecitabine and Oxaliplatin Versus Classic XELOX in Egyptian Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Colorectal cancer (CRC) in Egypt is advanced tumors at diagnosis. Although, the dramatic increase in efficacy, reduction of mortality, and improvements in survival by the use of standard doses of chemotherapy, some CRC patients suffer from severe toxicities besides disease progression. Use of chemotherapy less than the maximum tolerated dose, with no prolonged drug free breaks incapacitates the cells to engage in progression mechanisms, suggesting that it could be a better alternative to standard dose therapy with better toxicity profile
Detailed Description
This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University between January 2016 and June 2018). Patients were randomly treated with either classic XELOX (arm A) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly X 8 weeks) then 2 weeks rest (arm B). Toxicities and the survival analysis after two years for both regimens were recorded. Blood samples are taken from both groups to assess pharmacokinetics of capecitabine and its relation to dosing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Response, Toxicity, Survival
Keywords
colorectal cancer, metronomic capecitabine
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Classic (A)
Arm Type
Active Comparator
Arm Description
patients recieving classic XELOX (oxaliplatin 130mg/m2 and capecitabine 1000mg/m2 bid)
Arm Title
metronomic (B)
Arm Type
Experimental
Arm Description
patients recieving low dose capecitabine (2000mg daily divided in two doses for 8 weeks) and oxaliplatin (30mg/m2 weekly for eight weeks) followed by 2 weeks rest.
Intervention Type
Drug
Intervention Name(s)
metronomic XELOX
Other Intervention Name(s)
Capecitabine, Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Classic XELOX
Other Intervention Name(s)
Capecitabine, Oxaliplatin
Intervention Type
Other
Intervention Name(s)
Blood samples for pharmacological studies
Other Intervention Name(s)
No other names
Primary Outcome Measure Information:
Title
response rates
Description
Calculated with 95% confidence interval
Time Frame
two years
Title
Rate of toxicities and grades
Description
Categorical data summarized by pecentages
Time Frame
two years
Title
Peak and trough levels of capecitabine and relation to dosing
Description
Numerical data summarized by means and standard deviation
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Cox proportional hazard model
Time Frame
two years
Title
Overall survival
Description
Kaplan and Meier test
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient age 18-70 years of both sexes.
PS 0-2 and histologically proven mCRC with unresectable metastases (rectal cancer is included to left side cancers).
They should have measurable lesions (that can be accurately measured in at least one dimension using calipers or ruler and measurement must be at least 20 mm using conventional techniques or 10 mm using spiral CT scan).
No previous treatment for metastatic disease and had ended adjuvant treatment > 6 months.
peripheral neuritis less than grade 2.
Normal organ functions:(Creatinine ≤1.2, Bilirubin ≤1.2, SGOT/SGPT< 2N, HB >9gm/dl, WBC>3.5/dl with ANC >1.5/dl, Plat ≥100/dl).
For patients with liver metastases, Bilirubin should not be >2.5N and transaminases not >5N. (All patients were screened for HCV and HBS Ag by PCR).
Adequate cardiac functions (EF>55%)
Exclusion Criteria:
patients with only ascites or bone metastasis
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients
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