Clinical Study Evaluating the Anticancer Effect of Pentoxiphylline in Patients With Metastatic Colorectal Cancer

Prior treatment

• Patients on chronic use of corticosteroids.
• Patients receiving blood thinning agents(aspirin, clopidogrel, warfarin)
• Prior exposure to neurotoxic drugs (oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH) for at least 6 months prior the study treatment.

Other illness

• Patients with active liver diseases (chronic viral hepatitis, autoimmune hepatitis, alcoholic hepatitis, Wilson's disease, hemochromatosis, or cirrhosis).
• Patients with active infection.
• Patients with other malignancy (synchronous, or metachronous)
• Evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes, brain tumor, brain trauma, HCV, thyroid disorder).
• Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C.
• History of known allergy to oxaliplatin or other platinum agents.

Lab values

• Patients with moderate and severe renal impairment (CrCl \<50 ml/min) or serum creatinine \>1.5 mg/dl.

Other

• Patients with brain metastasis.
• Pregnant and breastfeeding women.

• Patients with histologically and/or radiologically confirmed diagnosis of metastatic colorectal carcinoma.
• Both genders.
• Age ≥ 18 years old, and ≤ 75 years old.
• Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG).
• Patients with adequate hematologic parameters (white blood cell count
  • ≥3000/mm3, granulocytes ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 8 gm/l).
• Patients with adequate renal functions (serum creatinine ≤1.5 mg/dL).
• Patients with adequate hepatic functions (bilirubin ≤1.5 mg/dL or albumin ≥3 g/dL).