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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this work is to assess the antitumor effect of Pentoxiphylline in patients with metastatic colorectal cancer receiving stomatal chemotherapy ± targeted therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tanta University
• Treatments: Antibodies; Antibodies, Monoclonal; Pentoxifylline

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Patients with active liver diseases (chronic viral hepatitis, autoimmune hepatitis, alcoholic hepatitis, Wilson's disease, hemochromatosis, or cirrhosis).

• Patients with brain metastasis.

• Patients with active infection.

• Patients on chronic use of corticosteroids.

• Patients receiving blood thinning agents(aspirin, clopidogrel, warfarin)

• Patients with other malignancy (synchronous, or metachronous)

• Prior exposure to neurotoxic drugs (oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH) for at least 6 months prior the study treatment.

• 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.

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

• Pregnant and breastfeeding women.