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

NCT04425564 | Completed Phase 2 DMC

• 1 other identifier: 201516007.3
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Clinical Response; Toxicity; Survival

Keywords

colorectal cancer; metronomic capecitabine

Outcome Measures

Primary Outcomes (3)

• response rates

  Calculated with 95% confidence interval

  two years

• Rate of toxicities and grades

  Categorical data summarized by pecentages

  two years

• Peak and trough levels of capecitabine and relation to dosing

  Numerical data summarized by means and standard deviation

  Two years

Secondary Outcomes (2)

• Progression free survival

  two years

• Overall survival

  Two years

Study Arms (2)

Classic (A)

ACTIVE COMPARATOR

patients recieving classic XELOX (oxaliplatin 130mg/m2 and capecitabine 1000mg/m2 bid)

Drug: Classic XELOX; Other: Blood samples for pharmacological studies

metronomic (B)

EXPERIMENTAL

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.

Drug: metronomic XELOX; Other: Blood samples for pharmacological studies

Interventions

metronomic XELOX DRUG

Also known as: Capecitabine, Oxaliplatin

metronomic (B)

Classic XELOX DRUG

Also known as: Capecitabine, Oxaliplatin

Classic (A)

Blood samples for pharmacological studies OTHER

Also known as: No other names

Classic (A); metronomic (B)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• patients with only ascites or bone metastasis

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 11, 2020
• Study Start: January 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: December 31, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share