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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
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Clinical Response focused on measuring colorectal cancer, metronomic capecitabine

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 2, 2020
    Last Updated
    June 6, 2020
    Sponsor
    National Cancer Institute, Egypt
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    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

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    Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients

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