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

Launched by TANTA UNIVERSITY · Nov 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the potential benefits of a drug called Pentoxiphylline for patients with metastatic colorectal cancer, which means the cancer has spread to other parts of the body. The goal is to see if this medication can help improve the effects of chemotherapy and targeted therapies that patients are already receiving. The study is currently not recruiting participants, but it aims to include adults aged 18 to 75 who have been diagnosed with metastatic colorectal cancer and meet certain health criteria.

To participate, patients need to be in relatively good health, as shown by specific blood tests and overall health status. However, those with certain conditions, such as active liver diseases or brain metastases, will not be eligible. If someone qualifies and decides to join, they will be monitored closely throughout the study to assess how well Pentoxiphylline works alongside their current treatment. This trial represents an important step in understanding new ways to potentially improve care for patients dealing with advanced colorectal cancer.

Gender

ALL

Eligibility 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.