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

NCT06115174 | Unknown Phase 4

• 1 other identifier: Pentoxiphylline in CRC
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colorectal Carcinoma

Outcome Measures

Primary Outcomes (4)

• Comparison of RECIST between the two groups.

  Difference in response rate (RECIST) between the control and drug groups.

  one year

• Change in the serum concentration of the measured biological markers.

  one year

• Difference in progression free survival 'PFS' between the two groups

  One year.

• Difference in overall survival 'OS' between the two groups.

  One year.

Study Arms (2)

People not recieving the drug

OTHER

(Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX (oxaliplatin + capecitabine) ± target therapy (Bevacizumab).

Radiation: FOLFOX; Radiation: XELOX; Drug: Monoclonal antibodies (target therapy)

People recieving the drug

ACTIVE COMPARATOR

(Pentoxiphylline group; n=22) which will receive the same FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX regimen (oxaliplatin + capecitabine) ± target therapy (Bevacizumab) in addition to Pentoxiphylline 400 mg twice daily.

Drug: Pentoxifylline; Radiation: FOLFOX; Radiation: XELOX; Drug: Monoclonal antibodies (target therapy)

Interventions

Pentoxifylline DRUG

Pentoxifylline (PTX) is a methylxanthine derivative that is commercially available in the name of Trental. It is currently used for management of peripheral vascular diseases. Its postulated mechanism of action is thought to be mediated through reducing blood viscosity and enhancing RBCs flexibility. However, it has been shown that PTX also may potentially be used in the anticancer therapy \[15\]. The studies demonstrated the potential effects of pentoxifylline on angiogenesis inhibition. It can affect the release and function of some predominantly proangiogenic vascular endothelial growth factors. Specifically, the release of the VEGF family of pro-angiogenesis factors (notably VEGF-A and VEGF-C) \[16\]. Furthermore, the mechanism by which pentoxifylline inhibits angiogenesis may be through the inhibition of activation of STAT3 which contributes to tumor cell survival by regulating the expression of metastatic genes, MMPs, serine protease uPA and potent angiogenic genes \[17\].

People recieving the drug

FOLFOX RADIATION

(leucovorin, fluorouracil, oxaliplatin)

People not recieving the drug; People recieving the drug

XELOX RADIATION

(oxaliplatin + capecitabine)

People not recieving the drug; People recieving the drug

Monoclonal antibodies (target therapy) DRUG

target therapy (Bevacizumab).

People not recieving the drug; People recieving the drug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (19)

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  BACKGROUND

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Pentoxifylline; Folfox protocol; XELOX; Antibodies, Monoclonal

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)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tarek Mohammed, Professor

  Tanta University

  STUDY CHAIR

• Dalia Refaat, Assistant Professor

  Tanta University

  STUDY CHAIR

• Sherif Refaat, Lecturer

  Oncology Centre - Faculty of Medicine - Mansoura University

  STUDY CHAIR

Central Study Contacts

Nada Abu Eleneen, Bachelor of Clinical Pharmacy

CONTACT

+201118161137; nada.enx1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Clinical Pharmacy (2021) - Faculty of Pharmacy - Mansoura University

Model Details: The design of this study is a randomized, controlled parallel clinical trial which will be conducted on 44 patients with metastatic colorectal cancer. The duration of the study will be one year to determine progression free survival (PFS) and the overall survival (OS). Patients will be recruited from Medical Oncology Department, Oncology Centre, Mansoura University, Mansoura, Egypt. The patients will be randomized using sealed envelope method into the following two groups: Group I (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX (oxaliplatin + capecitabine) ± target therapy (Bevacizumab). Group II: (Pentoxiphylline group; n=22) which will receive the same FOLFOX or XELOX regimen ± target therapy (Bevacizumab) in addition to Pentoxiphylline 400 mg twice daily.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share