Status:
UNKNOWN
Clinical Study Evaluating the Anticancer Effect of Pentoxiphylline in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Tanta University
Conditions:
Metastatic Colorectal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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.
Detailed Description
Colorectal cancer (CRC) ranks as the third most common cancer globally and second in terms of mortality. Although CRC incidence rates are higher in high-income compared with low-to-middle-income count...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06115174
Start Date
November 1 2023
End Date
December 1 2024
Last Update
November 2 2023
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