Clinical trial · Interventional
Clinical Study Evaluating the Anticancer Effect of Pentoxiphylline in Patients With Metastatic Colorectal Cancer
NCT06115174CI-TRIAL-00071026CRC - PTXunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX | Radiation | — | UNRESOLVED |
| Monoclonal antibodies (target therapy) | Drug | — | UNRESOLVED |
| Pentoxifylline | Drug | — | UNRESOLVED |
| XELOX | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- People not recieving the drug
- description
- (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, oxaliplatin) or XELOX (oxaliplatin + capecitabine) ± target therapy (Bevacizumab).
- interventionNames
- Radiation: FOLFOX
- Radiation: XELOX
- Drug: Monoclonal antibodies (target therapy)
- type
- ACTIVE_COMPARATOR
- label
- People recieving the drug
- description
- (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.
- interventionNames
- Drug: Pentoxifylline
- Radiation: FOLFOX
- Radiation: XELOX
- Drug: Monoclonal antibodies (target therapy)
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (19)
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDFerlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M, Gavin A, Visser O, Bray F. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018 Nov;103:356-387. doi: 10.1016/j.ejca.2018.07.005. Epub 2018 Aug 9. PMID 30100160
- BACKGROUNDArnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27. PMID 26818619
- BACKGROUNDSchreuders EH, Ruco A, Rabeneck L, Schoen RE, Sung JJ, Young GP, Kuipers EJ. Colorectal cancer screening: a global overview of existing programmes. Gut. 2015 Oct;64(10):1637-49. doi: 10.1136/gutjnl-2014-309086. Epub 2015 Jun 3. PMID 26041752
- BACKGROUNDSankaranarayanan R. Screening for cancer in low- and middle-income countries. Ann Glob Health. 2014 Sep-Oct;80(5):412-7. doi: 10.1016/j.aogh.2014.09.014. PMID 25512156
- BACKGROUNDHaggar FA, Boushey RP. Colorectal cancer epidemiology: incidence, mortality, survival, and risk factors. Clin Colon Rectal Surg. 2009 Nov;22(4):191-7. doi: 10.1055/s-0029-1242458. PMID 21037809
- BACKGROUNDMarley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016. PMID 27766137
- Vuik FE, Nieuwenburg SA, Bardou M, Lansdorp-Vogelaar I, Dinis-Ribeiro M, Bento MJ, Zadnik V, Pellise M, Esteban L, Kaminski MF, Suchanek S, Ngo O, Majek O, Leja M, Kuipers EJ, Spaander MC. Increasing incidence of colorectal cancer in young adults in Europe over the last 25 years. Gut. 2019 Oct;68(10):1820-1826. doi: 10.1136/gutjnl-2018-317592. Epub 2019 May 16.