Clinical trial NCT04425564: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clinical Response
Toxicity
Survival
Keywords: colorectal cancer
metronomic capecitabine
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: response rates
timeFrame: two years
measure: Rate of toxicities and grades
timeFrame: two years
measure: Peak and trough levels of capecitabine and relation to dosing
timeFrame: Two years
Secondary outcomes:
measure: Progression free survival
timeFrame: two years
measure: Overall survival
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
References: