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

Survival Clinical Trial

Official title:

Clinico-pharmacological Study of Metronomic Capecitabine and Oxaliplatin Versus Classic XELOX in Egyptian Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425564
• Other study ID #: 201516007.3
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2020
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Response
• Colorectal Neoplasms
• Survival
• Toxicity

Intervention

Drug:
• metronomic XELOX

• Classic XELOX

Other:
• Blood samples for pharmacological studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rates	Calculated with 95% confidence interval	two years
Primary	Rate of toxicities and grades	Categorical data summarized by pecentages	two years
Primary	Peak and trough levels of capecitabine and relation to dosing	Numerical data summarized by means and standard deviation	Two years
Secondary	Progression free survival	Cox proportional hazard model	two years
Secondary	Overall survival	Kaplan and Meier test	Two years