- |||||||||| 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
Trial completion date, Metastases: Rectal Cancer, Adjuvant Chemotherapy, FOLFOX(5-fluorouracil/Leucovorin/Oxaliplatin), Total Mesorectal Excision (clinicaltrials.gov) - Apr 22, 2021 P2, N=90, Active, not recruiting, Trial completion date: Sep 2021 --> May 2021 | Trial primary completion date: Sep 2021 --> May 2021 Trial completion date: May 2021 --> Aug 2021
- |||||||||| Avastin (bevacizumab) / Roche
Trial completion date, Trial primary completion date, Surgery: Bevacizumab, Fluorouracil, Leucovorin Calcium, and Oxaliplatin Before Surgery in Treating Patients With Stage II-III Rectal Cancer (clinicaltrials.gov) - Apr 22, 2021 P2, N=17, Active, not recruiting, Trial completion date: May 2021 --> Aug 2021 Trial completion date: Aug 2020 --> Aug 2022 | Trial primary completion date: May 2020 --> Aug 2021
- |||||||||| Enrollment open, Trial completion date, Trial primary completion date, Metastases: Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer (clinicaltrials.gov) - Apr 19, 2021
P2, N=30, Recruiting, Not yet recruiting --> Recruiting | Trial completion date: May 2021 --> Oct 2021 | Trial primary completion date: May 2020 --> Oct 2021 Not yet recruiting --> Recruiting | Trial completion date: Apr 2021 --> Oct 2021 | Trial primary completion date: Apr 2020 --> Oct 2021
- |||||||||| Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, P2 data, Journal, Combination therapy, Tumor Mutational Burden, MSi-H Biomarker, PD(L)-1 Biomarker, IO biomarker: Phase II study on first-line treatment of NIVolumab in combination with folfoxiri/bevacizumab in patients with Advanced COloRectal cancer RAS or BRAF mutated - NIVACOR trial (GOIRC-03-2018). (Pubmed Central) - Apr 17, 2021 P2 have been enrolled. NIVACOR is registered at ClinicalTrials.gov: NCT04072198 , August 28, 2019.
- |||||||||| leucovorin calcium / Generic mfg., cisplatin / Generic mfg., doxorubicin hydrochloride / Generic mfg.
[VIRTUAL] METHOTREXATE USE IN END-STAGE RENAL DISEASE: A CASE REPORT () - Apr 14, 2021 - Abstract #ASPHO2021ASPHO_545; On week 4,5,9 and 10 of therapy she received methotrexate at 25% of protocol dose (3 gm/m^2 in place of 13 gm/m^2), with high dose leucovorin 50 mg/m2, with twice daily hemodialysis and cleared methotrexate at ~120 hours after each dose... Methotrexate can safely be used in renal failure with an interdisciplinary approach.
- |||||||||| leucovorin calcium / Generic mfg., vincristine / Generic mfg.
[VIRTUAL] SIGNIFICANTLY DELAYED METHOTREXATE CLEARANCE IN A PATIENT WITH PRE-B ALL AND COVID-19 () - Apr 14, 2021 - Abstract #ASPHO2021ASPHO_476; This is a case of significantly delayed methotrexate clearance in a patient with HR pre-B ALL in the setting of asymptomatic COVID-19 infection. Further research is needed to characterize the effect of COVID-19 on these patients in order to make recommendations for treatment modifications when these patients have COVID-19 infections.
- |||||||||| Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda, PharmaEngine
Clinical, P2 data, Journal: NET-02 trial protocol: a multicentre, randomised, parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC). (Pubmed Central) - Apr 14, 2021 P2 Results will be published in peer-reviewed journals and uploaded to the European Union Clinical Trials Register. ISRCTN10996604, NCT03837977, EudraCT Number: 2017-002453-11.
- |||||||||| etrumadenant (AB928) / Arcus Biosci, Gilead, quemliclustat (AB680) / Arcus Biosci, Gilead
Enrollment open, Metastases: ARC-9: An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer. (clinicaltrials.gov) - Apr 13, 2021 P1b/2, N=250, Recruiting, ISRCTN10996604, NCT03837977, EudraCT Number: 2017-002453-11. Not yet recruiting --> Recruiting
- |||||||||| Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
[VIRTUAL] Real-World Characteristics and Outcomes of Patients with Metastatic Ductal Adenocarcinoma (MPDAC) Treated with Liposomal Irinotecan-Based Regimens By Race () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_380; Similarly, results from the pivotal phase 3 study, NAPOLI-1, and recent literature suggest that participants of East Asian ethnic origin experience better outcomes than other ethnic groups with liposomal irinotecan+5-fluorouracil/leucovorin following gemcitabine...CONCLUSIONS : This analysis found racial disparities may persist in survival outcomes among patients with mPDAC treated with liposomal irinotecan-based regimens. Further studies are needed to characterize and understand the biological and socio-economic factors contributing to these disparate outcomes.
- |||||||||| 5-fluorouracil / Generic mfg.
[VIRTUAL] 5-Fluorouracil-induced Hand-Foot Syndrome Mimicking Gottron's Papules () - Apr 10, 2021 - Abstract #AADVMX2021AAD_VMX_423; Patients with this form of HFS are at risk of being misdiagnosed with dermatomyositis (DM) given their underlying malignancy. Recognizing that 5-FU and capecitabine can cause HFS affecting the dorsal hand may prevent unnecessary DM work-up in patients receiving these medications.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, emilumenib succinate (DS-1594) / Daiichi Sankyo
Enrollment open, Trial initiation date, Combination therapy: DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Apr 7, 2021 P1/2, N=122, Recruiting, Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Initiation date: Jul 2021 --> Mar 2021
- |||||||||| methotrexate / Generic mfg.
Preclinical, Journal: Long-term clinically relevant rodent model of methotrexate-induced cognitive impairment. (Pubmed Central) - Apr 7, 2021 These results demonstrate a significant negative impact of methotrexate on the oligodendrocyte compartment and white matter, associated with cognitive impairment. The data also support the use of diffusion tensor imaging in monitoring white matter integrity in this context.
- |||||||||| cisplatin / Generic mfg.
Clinical, P3 data, Journal: Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. (Pubmed Central) - Apr 7, 2021 P3 To our knowledge, this trial is the first prospective, randomised study providing reliable, high-quality evidence to allow an informed discussion with patients of the potential benefits and risks from second-line FOLFOX chemotherapy in advanced biliary tract cancer. Based on these findings, FOLFOX should become standard-of-care chemotherapy in second-line treatment for advanced biliary tract cancer and the reference regimen for further clinical trials.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, P3 data, Journal, HEOR, Mismatch repair, Microsatellite instability: Health-related quality of life in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer treated with first-line pembrolizumab versus chemotherapy (KEYNOTE-177): an open-label, randomised, phase 3 trial. (Pubmed Central) - Apr 7, 2021 P3 Pembrolizumab monotherapy led to clinically meaningful improvements in HRQOL compared with chemotherapy in patients with previously untreated microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. These data, along with the previously reported clinical benefits, support pembrolizumab as a first-line treatment option for this population.
- |||||||||| Tomudex (raltitrexed) / Pfizer, AstraZeneca
Journal: Tolerability of pemetrexed and oxaliplatin in the treatment of stage III colon cancer during raltitrexed shortage. (Pubmed Central) - Mar 30, 2021 However, the patient also experienced progressive neuropathy which required a dose reduction and subsequent discontinuation of oxaliplatin. Overall, pemetrexed and oxaliplatin's tolerability seems comparable to other regimens used to treat colorectal cancer and could potentially be an option to consider in the future for alternative treatment of colorectal cancer pending further trials.
- |||||||||| Biomarker, Review, Journal, Tumor microenvironment: Hedgehog signaling in gastrointestinal carcinogenesis and the gastrointestinal tumor microenvironment. (Pubmed Central) - Mar 30, 2021
Furthermore, aberrant HH signaling activation is favorable to both the proliferation of cancer stem cells (CSCs) and the drug resistance of gastrointestinal tumors. This review discusses the current understanding of the role and mechanism of aberrant HH signaling activation in gastrointestinal carcinogenesis, the gastrointestinal TME, tumor immune tolerance and drug resistance and highlights the underlying therapeutic opportunities.
- |||||||||| Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
Enrollment closed, Trial completion date, Trial primary completion date: T2317: Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy (clinicaltrials.gov) - Mar 30, 2021 P2, N=59, Active, not recruiting, This review discusses the current understanding of the role and mechanism of aberrant HH signaling activation in gastrointestinal carcinogenesis, the gastrointestinal TME, tumor immune tolerance and drug resistance and highlights the underlying therapeutic opportunities. Not yet recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
|