Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Crizotininb: Oncology Drug used for treatment of ALK positive non small cell lung cancer
Intervention2: Crizotinib with Chemotherapy: Patients will receive chemotherapy with pemetrexed
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age>= 18 years 2.Histologically or cytologically confirmed non-small cell lung carcinoma with ALK Mutation 3.Planned for palliative intent therapy, i.e. disease not amenable to curative intent therapy 4.No prior palliative chemotherapy, or palliative biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VGEF) inhibitors) or immunological therapy. 5.Adequate renal, liver, cardiac and bone marrow function defined as -Creatinine = 45ml/min -AST, ALT 2.5gm/dl -Left ventricular Ejection Fraction >= the lower limit of normal by ECHO -Haemoglobin >=8gm/dl, Absolute neutrophil count >= 1200/mm3, Platelets>=1,00,000/mm3 6. Measurable disease according to RECIST criteria with at least one measurable lesion not previously irradiated 7. ECOG performance status (PS) of 0 to 2 8. Patients must be willing to complete EORTC QOL. 9. Patients willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Known severe hypersensitivity to Pemetrexed or Carboplatin or any of the excipients of these products 2. Known severe hypersensitivity to pre-medications required for treatment with Pemetrexed chemotherapy 3. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 4. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study. 5. Pregnancy or breast feeding. In patients of reproductive age, a serum B â??HCG would be performed to rule out pregnancy. 6. Life expectancy of 7. Treatment with a non-approved or investigational drug within 30 days before first day of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the disease control rate at 6 months between patients treated with chemotherapy combined with crizotinib as compared with crizotinib alone 2.To evaluate PFS in patients treated with chemotherapy combined with crizotinib as compared to crizotinib aloneTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate response rate, toxicities and QOL (EORTC Q30 and LC13) 2.To evaluate response rates, overall survival, side effects, toxicities and QOL (EORTC Q30 and LC13Timepoint: 4 years | — |
Countries
India
Contacts
Public ContactDr Kumar Prabhash
Tata Memorial Hospital
Outcome results
None listed