Health Condition 1: null- Radiation induced Mucositis in Head and Neck cancer
Conditions
Interventions
Intervention1: P276-00: P276-00 will be administered at a dose of 100 mg/m2/day as an intravenous infusion in 5% dextrose over 30 minutes on Days 1 through 5 every 21 days (Week 1, Week 4 and Week 7)
Sponsors
Piramal Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to understand and willing to give an informed consent for the study. 2. Pathologically (histologically or cytologically) confirmed (from primary tumor and/or lymph nodes), non-metastatic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx eligible for treatment with concomitant chemoradiation as first-line treatment; subjects with a history of surgical management are not eligible 3. Have a plan to receive a continuous course of radiation (3DRT or IMRT) as single daily fractions of 2.0 Gy, with a cumulative radiation dose between 66 and 70 Gy. Planned radiation treatment fields must include at least 2 oral sites (maxillary or mandibular labial mucosa, right or left buccal mucosa, right or left floor of the mouth, ventral tongue, right or left lateral tongue, or soft palate), with each site receiving >= 50 Gy 4. Have a plan to receive a standard cisplatin regimen administered weekly (30 to 40 mg/m2) 5. Have an Eastern Co-operative Oncology Group (ECOG) performance status 6. Males or females aged 18 years or older 7. Pre-treatment dental procedures must be completed with recovery and the prophylactic insertion of gastric feeding tubes (if planned) prior to entry into the study 8. Adequate bone marrow function measured within two weeks prior to enrollment based upon CBC/differential, defined as follows: a) Absolute neutrophil count (ANC) >= 1,500 cells/mm3 b) Platelets >= 100,000 cells/mm3 c) Hemoglobin (Hb) >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hb >= 8.0 g/dl prior to the start of RT is acceptable) 9. Adequate hepatic function measured within two weeks prior to enrollment defined as follows: a) Bilirubin b) AST c) ALT 10. Adequate renal function measured within two weeks prior to enrollment and defined as follows a) Serum creatinine b) Creatinine clearance (CC) >= 60 ml/min determined by 24-hour urine collection or estimated by the Cockcroft-Gault formula: 11. Have a negative serum pregnancy test for women of childbearing potential at time of screening and negative urine pregnancy test within 72 hrs prior to first dose of study drug 12. Willing and able to complete the daily diary questionnaire either by themselves or with assistance.
Exclusion criteria
Exclusion criteria: 1. Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor 2. Metastatic disease (M1) Stage IVC as per the AJCC, 7th edition 3. Prior radiation to the head and neck 4. Have undergone induction CT 5. History of malignant tumors other than HNC (except non-melanoma skin cancer) unless disease free for a minimum of 3 years 6. Severe comorbidity, defined as: a) Symptomatic and/or uncontrolled cardiac disease, New York Heart Association (NYHA) Classification III or IV b) Acute myocardial infarction within the last 6 months c) Acute bacterial or fungal infection requiring systemic antibiotics at the time of enrollment d) Subjects known to be seropositive for human immunodeficiency virus (HIV) or subjects with Acquired Immune Deficiency Syndrome (AIDS), known current acute or chronic Hepatitis B, known Hepatitis C (antigen positive), or hepatic cirrhosis e) Subjects with active tuberculosis f) Collagen vascular disease, such as scleroderma, as this is thought to predispose subjects to increased risk for radiation-associated toxicities 7. Have used any other investigational drug therapy within 1 month prior to Day 1 of study drug administration or non-recovery (to Grade ï?£ 1) from adverse effects of the investigational agent received prior to this period 8. Prior allergic reaction to any of the agents administered during the course of treatment 9. Have QTcF 450 msec at screening 10. Pregnant or breastfeeding women 11. Have any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which in the opinion of the Investigator, would either compromise the patientâ??s safety, interfere with evaluation of the study drug, or make the subject unsuitable for the study or unable to comply with follow-up visits. 12. Sexually active female subjects of childbearing potential and male subjects with partner of child-bearing potential unwilling to use adequate contraception from the time of signing informed consent document, throughout the duration of the study and for atleast 3 months after end of study treatment or following withdrawal from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of severe (WHO Grade â?¥ 3) Radiation Induced Mucositis (RIM)Timepoint: Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade â?¤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of severe RIM (WHO Grade â?¥ 3)Timepoint: Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade â?¤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first.;Time to onset of severe RIM (WHO Grade â?¥ 3)Timepoint: Mucositis assessment will be performed by treatment-blinded, trained evaluators twice weekly (at least 48 hours apart) within each 5 day RT treatment week during the radiation period, including treatment breaks. Twice weekly assessments will continue following the end of RT until WHO Grade â?¤ 2 or until 8 weeks after Last Day of RT (Week 15 from start of study treatment), whichever occurs first. | — |
Countries
India
Contacts
Public ContactDr Sandesh Sawant
Piramal Healthcare Limited
Outcome results
None listed