Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified
Conditions
Interventions
Intervention1: Palliative chemotherapy: weekly paclitaxel 80mg/m2
Control Intervention1: Palliative chemotherapy and Naltraxone: weekly paclitaxel 80mg/m2 + naltrexone would be 0.1mg/kg body weight to
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma esophageal or gastro-esophageal junction region. 2. Participants must have metastatic/recurrent/locally advanced disease and planned for palliative chemotherapy 3. ECOG performance status 4.Participants must have normal organ and marrow function as defined below: a.Leukocytes >=3,000/mcL b.Platelets >=100,000/mcL c.Total bilirubin d. AST(SGOT)/ALT(SGPT) e. Calculated Creatinine clearance >30 ml/min 5. The effects of chemotherapy on the developing human fetus are teratogenic. Hence women of childbearing potential 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.
Exclusion criteria
Exclusion criteria: 1.Patients having recurrent disease and planned for definitive therapy would be excluded 2.Patients who are eligible for targeted therapy 3.Participants who are receiving any other investigational agents. 4.Having present or past (within last 2 years) second primary sites of malignancy. 5.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study. 6.Uncontrolled inter-current illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), hepatic failure (Child-Pugh B or C), active gastrointestinal bleeding or obstruction, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements. 7.Pregnant women and breastfeeding women are excluded from this study 8.HIV-positive, Hepatitis B and C seropositive patients are excluded from this study. 9.Patients requiring Opioids( Morphine) will be excluded from study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression Free Survival 2. Overall Survival Timepoint: 1.PFS: At progression 2. OS: At Death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To compare the overall response rate between the two arms of chemotherapy and chemotherapy with naltrexone 2 To compare the grade 3-4 toxicity between the two arms 3 To compare the QOL score between the two arms.Timepoint: 1 After two to three months 2 After every visit 3 Every visit and two to three months | — |
Countries
India
Contacts
Public ContactDr Amit Joshi
Tata Memorial Hospital
Outcome results
None listed