Health Condition 1: null- All Patients who are having Lung cancer
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Gefitinib: Dosage Regimen
Gefitinib:250 mg OD
Erlotinib and gefitinb both works as tyrosine kinase inhibitors. This inhibits EGFR
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed NSCLC failed to first line chemotherapy in palliative setting. 2. Age more than 18 years; 3. Performance status 4. Estimated life expectancy of at least 12-weeks; 5. Adequate organ and immune system function as indicated by the following laboratory values, obtained System Lab value Hematologic ANC >= 1.5 Ã? 109 /L Hb >= 9.0 g/dL Platelets >= 100 Ã? 109 /L Renal Sr. Creatinine Hepatic Total Bilirubin AST ALT Alkaline Phosphatase 6. Any chemotherapy must have been completed before enrollment in this trial 7. Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or log acting injected contraceptives] from at least 2 months prior to trial entry and through the duration of the trial; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the patient); with a negative urine pregnancy test; 8. Willing to participate and give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Hematological malignancies including leukemia, lymphoma or multiple myeloma; 2. Uncontrolled angina, patients with a history of myocardial infarction within 1-month of enrollment, or patients with cardiac functional capacity Class III or IV as defined by NYHA classification; 3. Known hypersensitivity to trial drugs or its excipients or analogs; 4. Treatment with any investigational agents within 30-days of trial entry; 5. Active and uncontrolled infection; 6. Psychiatric disorders or alcohol/chemical abuse that would interfere with consent or follow-up; 7. Presence of clinically not stable CNS metastases or carcinomatous meningitis; 8. Any other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this trial; 9. HIV positive or who have an AIDS-related illness; 10. Prior bone marrow/stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Skin toxicity as per CTCAE Timepoint: Skin toxicity will be assessed at every follow up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, Quality Of Life (EORTC Q30, LC13 and Functional Assessment of Cancer Therapy-EGFRI 18 ), Overall Survival, Response Rate and other safety parameters. Timepoint: QOl will be assessed at every visit and Response will be assessed at every 2 months | — |
Countries
India
Contacts
Public ContactDr Kumar Prabhash
Tata Memorial Hospital
Outcome results
None listed