A study to check if the new regimen of EMF(Erlotinib/Methotrexate/ 5- FU) is safe and helpful in treating recurrent Head and neck cancer.

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Annie Kanchan Baa, Atul Sharma, Mayank Singh, Ashna Gupta, Ahitagni Biswas et al. (9 authors)

Indian Journal of Medical and Paediatric Oncology2024-12-13

10.1055/s-0044-1792008

A single-arm feasibility phase II study of EMF (erlotinib + methotrexate + 5-fluorouracil) regimen in platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)

Annie Kanchan Baa, Atul Sharma, Suman Bhaskar, Ahitagni Biswas, Sacchidanand JeeBharti et al. (8 authors)

ecancermedicalscience2022-09-293 citations

10.3332/ecancer.2022.1451

A feasibility study of EMF(erlotinib+methotrexate+5-fluorouracil) regimen in recurrent head and neck squamous cell carcinoma (HNSCC) and role of circulating tumour cells(CTCs) in assessment of outcomes.

Annie Kanchan Baa, Raja Pramanik, Atul Sharma, Ahitagni Biswas, Sachidanand JeeBharti et al. (12 authors)

Journal of Clinical Oncology2022-06-01

10.1200/jco.2022.40.16_suppl.e18038

Interventions

Intervention1: EMF Regimen Erlotinib/Methotrexate/5-FU: Tab Erlotinib 150mg daily Inj. Methotrexate 40mg/m2 ivp on D1 and D8 Inj. 5-Fluorouracil 500mg/m2 ivp on D1 and D8 (premedication will incl

Eligibility

Inclusion criteria

Inclusion criteria: a) Histopathological diagnosis of squamous cell carcinoma of head and neck region. b) ECOG PS 0-2 c) Recurrence of disease within 6 months after definitive or on palliative therapy. d) Previous exposure to platinum agents either as chemotherapy or part of concurrent Chemo-radiotherapy. e) Recurrence after treatment with PDL1 inhibitors. f) Adequate organ function: - Bone marrow function: ANC >1000/mm3, platelets > 100000/mm3 -LFTs: S.bilirubin - RFT: Within normal limits , eGFR >50ml/min g) Not affording Cetuximab ,Nivolumab & Pembrolizumab h) Measurable disease

Exclusion criteria

Exclusion criteria: a) Uncontrolled severe comorbidities b) HIV positivity, HBsAg or HCV related hepatitis c) Nasopharyngeal carcinoma/sino-nasal carcinoma

Design outcomes

Primary

Measure	Time frame
To assess the objective response rate [ORR; complete response (CR) + partial response (PR)].Timepoint: 3months	—

Secondary

Measure	Time frame
Evaluate the change in QOL and assess cfDNA as biomarker.Timepoint: 3months;To assess the progression free survival(PFS) and overall survival (OS)Timepoint: 3months	—

Countries

India

Contacts

Public ContactAnnie Kanchan Baa

All India Institute of Medical Sciences

drrajapramanik@gmail.com

Outcome results

None listed