Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Group A: IV methotrexate Dose-40 mg/m2 once a week plus oral Gefitinib 250 mg Tablet daily: Patients with residual / recurrent or metastatic SCCHN with Eastern Cooperative Oncology Grou
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically/ Cytologically confirmed Squamous cell carcinoma (SCC) of head and neck 2.age 18-65 years 3.Platinum naïve HNSCC, ECOG-2-3: Planned for Palliative intent therapy 4.Platinum resistant HNSCC, ECOG-0-3: Patients who had progressive disease on first-line platinum chemotherapy in recurrent/ metastatic SCC or residual disease with prior treatment with chemoradiotherapy as part of potentially curative intent within 6 months.
Exclusion criteria
Exclusion criteria: 1. Patients who are fit for salvage surgery / reirradiation for recurrent or residual disease/ platinum based chemotherapy 2. Pregnant or breast feeding or pregnant female patients 3. Patients having brain metastases. ? Patients with creatinineclearance less than 50 ml/min. 4. Uncontrolled medical comorbidities. 5. Patients with HIV positivity and hepatitis B virus or hepatitis C virus related hepatitis 6. Patients not willing for close follow up 7. Primary in Nasopharynx, Thyroid or Salivary glands 8. Major tumor related hemorrhagic events in the previous 3 months 9. On Therapeutic anticoagulation (warfarin) 10. With tumors that invaded major vessels 11. Any third space fluid accumulation (edema, ascites, effusion) 12.Known to be at risk of developing QT interval prolongation (e.g. hypokalemia, hypomagnesemia, bundle branch block, sinus node dysfunction) or with a known baseline QT interval >460 msec 13. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates 14. Prior treatment with an EGFR inhibitor or Methotrexate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: Median overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survivalTimepoint: Median Progression free survival;Overall Response rate Disease control rate Timepoint: ORR and DCR will be compared between two arms at study completion;Acute ToxicitiesTimepoint: Acute toxicity comparison between two arms will be done at study completion | — |
Countries
India
Contacts
Public ContactPooja Sethi
JIPMER , PUDUCHERRY
Outcome results
None listed