Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Paclitaxel and carboplatin with Oral Metronomic Chemotherapy: Patients on arm B will receive initially Paclitaxel (175mg/m2) plus Carboplatin (AUC 5) on day 1 in 3 weekly cycles. In ad
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Head and neck cancers planned for palliative chemotherapy not amenable for local therapy 2. Age : Any age more than or equal to 18 years 3. ECOG performance status less than or equal to 2 4. Histopathologically or FNAC (Fine needle aspiration cytology) proof of cancer. 5. Participants must have normal organ and marrow function as defined below: a.Leukocytes more than or equal to 3,000/mcL b.Platelets more than or equal to 100,000/mcL c.Total bilirubin less than 1.5 Ã? institutional upper limit of normal d.AST(SGOT)/ALT(SGPT) less than or equal to 2.5 Ã? institutional upper limit of normal e.Calculated Creatinine clearance more than 30 ml/min 6. The effects of chemotherapy on the developing human fetus are teratogenic. Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of protocol. 7. Both men and women of all races and ethnic groups are eligible for this trial. 8. Willing and able to comply with all study requirements. 9. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1. Participants who are currently receiving any other investigational agents. 2. Platinum refractory failure (failure within 6 months of reception of cisplatin or carboplatin as a part of multimodality curative treatment) or early failure (failure within 1 month of surgery or radiation). 3. Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of ondansetron. Patients in whom an initial evaluation QTc is prolonged but with medical interventions it is restored to normal are eligible for the study. 4. Patients receiving methotrexate medical indications not limited to rheumatoid arthritis or as who have received it either as neoadjuvant or adjuvant within last 2 years. 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 6. Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents within last 1 year , in�ammatory bowel disease, known hyperkalemia ( CTCAE version 4.03 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements. Patients who have uncontrolled hypertension or diabetes or other chronic medical condition at initial evaluation but in whom these conditions are controlled with medical intervention can be assessed for eligibility. 7. Pregnant women and breastfeeding women are excluded from this study because Chemotherapy agents have the potential for teratogenicity or abortifacient effects. 8. Patients who are unable to swallow.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: Progression Free survival Phase 3: Overall SurvivalTimepoint: Phase 2: The response would be monitored in accordance with institutional standards. That is after first 3 cycle and every 2 months therafter. Phase 3: After completion of study patients will be followed up every 2 months for overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological and Non-hematological Toxicities as per CTCAE Version 5.0Timepoint: During Day 1 and Day 7 of First cycle and at Day 1 of subsequent cycles;Quality of lifeTimepoint: TOI will be calculated in all arms from FACT Head and neck QOL proformas Baseline, 2 months,4 months and at 6 months post treatment completion | — |
Countries
India
Contacts
Public ContactDr Vijay Patil
Tata Memorial Hospital
Outcome results
None listed