Health Condition 1: null- patients who have metastatic, recurrent or locally advanced HNSCC that are unsuitable for loco-regional radical curative intent treatment and are planned for palliative chemotherapy (first-line)
Conditions
Interventions
Intervention1: Palliative chemotherapy combined with pantoprazole: Intravenous pantoprazole (at the dose determined from the first phase of the trial) administered 30-60 minutes before chemotherapy, r
combined with
Physician choice of palliative chemotherapy, which can consist of
a. Intravenous cisplatin 75 mg/m2every 21 days
or
b. OMCT: oral celecoxib 200 mg twice daily and oral methotrexate 15 mg/m2 weekly.
Control Intervention1: Palliative chemotherapy alone: Physician choice of palliative chemotherapy, which can cons
or
b. OMCT: oral celecoxib 200 mg twice daily and oral methotrexate 15 mg/m2 weekly.
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 [47] 3. Histologically or cytologically proven squamous cell carcinoma 4. Primary tumor originating in the oral cavity, oropharynx, hypopharynx, larynx or metastatic cervical lymphadenopathy of unknown primary 5. Planned for palliative intent chemotherapy 6. Not planned for cetuximab-based therapy 7. Normal pre-treatment hematological and biochemical parameters: a. Adequate bone marrow function (hemoglobin > 8 g/L, platelets > 80 x 109/L, absolute neutrophil count > 1.5 x 109/L) b. Adequate liver function (ALT/AST c. Adequate renal function (creatinine clearance > 45 ml/min) 8. Absence of uncontrolled medical comorbidity. 9. Willing and able to comply with all study requirements, including treatment (able to swallow tablets or the presence of a feeding tube) and able to follow up at regular intervals. 10. Signed, written informed consent
Exclusion criteria
Exclusion criteria: 1. Thyroid, nasopharynx or salivary gland primary. 2. Patient has received prior palliative intent chemotherapy for HNSCC. 3. Known hypersensitivity to pantoprazole 4. Contraindications to methotrexate or cisplatin chemotherapy 5. QTc prolongation (QTc prolonged more than 450 millisecond) 6. Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Participants with known hepatitis B or C infection will be allowed to participate provided that evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy. 7. Concurrent major illness that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety. 8. Presence of any psychological, familial, social or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse. 9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or agreeable to use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to enrollment. Men should either be surgically sterilized or agreeable touse a barrier method of contraception. 10. Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable. 11. Patients on other investigational drugs within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To find out the safe dose of intravenous pantoprazole when combined with intravenous cisplatin chemotherapy or oral metronomic chemotherapy consisting of oral daily celecoxib and weekly oral methotrexate for second phase of the studyTimepoint: At the End of phase I | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate 2. Overall survival (OS) 3. Toxicity 4. Quality of life (QoL) Timepoint: At the end of the treatament;1. Response rate 2. Overall survival (OS) 3. Toxicity 4. Quality of life (QoL) Timepoint: At the end of the treatament | — |
Countries
India
Contacts
Public ContactDr Vanita Norhna
Tata Memorial Hospital
Outcome results
None listed