None listed
Conditions
Interventions
Intervention1: TIP arm: TIP arm: Paclitaxel will be administered at a dose of 175mg/m2 as a 3-hour intravenous infusion on day 1
Ifsosfamide as a 2 hour intravenous infusion of Ifosfamide at a dose of 1.5 gm/m2 on days 1-5
Cisplatin as a 60 minutes continuous intravenous infusion of cisplatin at a dose of 75mg/m2 on Day 1 every 21 days.
Control Intervention1: TCF arm: Paclitaxel will be administered at a dose of 175 mg/
5-FU as 6 hours infusion at a dose of 750 mg/m2 on days 1-5
Cisplatin as a 60 minutes of intravenous infusion at a dose of 75 mg/m2 on day 1 every 21 days.
Inj filgrastim will be administered in both arms at a dose of 300 micrograms on days 6-10 of each cycle
Sponsors
Indian Cooperative Oncology Network ICON
Eligibility
Inclusion criteria
Inclusion criteria: Signed written informed consent 1) Patients must be willing and able to give written informed consent. Target population 2) Patients with histologically proven undifferentiated carcinoma or squamous cell carcinoma (except thyroid cancer) of the oral cavity, nasopharynx, oropharynx, hypopharynx, nasal cavity, paranasal sinus, or larynx 3) Patients with locally advanced, Stage III-IV (except M1), head and neck cancer. 4) Patients with at least one measurable lesion according to the RECIST criteria (Section 7.3.2.1). 5) Patients who have not been previously treated for head and neck cancer (surgery, radiation, and chemotherapy, etc) 6) Patients with ECOG Performance status of 0 - 1 (Appendix 3) 7) Patients with normal hematologic, hepatic, and renal function as defined by the following criteria: −Neutrophil count: ≥1,500/L −Platelet count: ≥100,000/L −Hemoglobin amount: ≥9.0 g/dL −Serum AST and serum ALT: ≤2.5 x upper normal limit of the each site serum total bilirubin: ≤1.25 x upper normal limit of each site −Serum creatinine: ≤upper normal limit of each site (in case of values above the upper normal limit, refer to the Calculated Creatinine Clearance 60 ml/min (see Appendix 6) 8) Patients with a life expectancy of at least 3 months. 9) Men and Women, with ages ranging from 18 to 75 years. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level 35 mIU/mL]. Even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
Exclusion criteria
Exclusion criteria: Sex and Reproductive Status Exceptions 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. 2) Women who are pregnant or breastfeeding 3) Women with a positive pregnancy test on enrollment or prior to study drug administration. 4) Sexually active males unwilling to practice contraception during the study Medical History and Concurrent Diseases 5) Patients with a history of another malignancy (except cured basal cell carcinoma of skin or cured carcinoma in-situ of uterine cervix) 6) Patients with organ allografts (kidney, liver, heart, and lung, etc) 7) Patients with clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) not well controlled with medication) or a myocardial infarction within the last 6 months 8) Patients with evidence of central nervous system metastases. 9) Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disabilities that may preclude adequate informed consent or compromise compliance with treatment, as judged by the investigator. 10) Patients with serious uncontrolled inter-current infections or HIV infection. 11) Patients with active gastrointestinal bleeding. 12) Patients who have undergone major surgery within 4 weeks of the start of study treatment. 13) Patients with pre-existing neuropathy ≥ CTC grade 2 (Appendix 4) Allergies and Adverse Drug Reactions 14) Patients with a history of hypersensitivity related to the administration of polyoxyethylene-castor-oil (Cremophor EL)(e.g., cyclosporin), or hardened castor oil (e.g., vitamin preparations for injection, etc). 15) Patients who received other investigational drug(s) within 6 months prior to study enrolment. 16) Patients that the investigator judges as inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the toxicity of TIP and TCF regimens when used in locally advanced HNC in neoadjuvant setting. Timepoint: To evaluate and compare the toxicity of TIP and TCF regimens when used in locally advanced HNC in neoadjuvant setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the tumor response of TIP and TCF in this population of patients.Timepoint: To assess the tumor response of TIP and TCF in this population of patients. | — |
Countries
India
Contacts
Public ContactDr Khurshid Mistry
Outcome results
None listed