Health Condition 1: null- Indian adult ChemoNaive Adenocarcinoma Non-small cell lung cancer patient
Conditions
Interventions
Intervention1: PEMGEM (Dr. Reddys Lab) 500 mg/m2 IV over 10 minute: Administered on day 1 of 21 days cycle, repeated over six cycles
Control Intervention1: ALIMTA (Eli Lilly) 500 mg/m2 IV over 10 min.
Sponsors
INVESTIGATOR INITIATED TRIAL
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients in the age group of 18 to 80 years inclusive of both years Patients with a histologic or cytologic diagnosis of Adenocarcinoma - NSCLC Stage IIIA, IIIB, or IV not amenable to curative treatment surgery or radiotherapy Patients must be chemo-naive Patients with an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 If Patients had received prior radiotherapy, then it must be Patients with ANC > 1500 cells/mm3 Patients with platelet count > 100,000 cells/mm3 Patients with hemoglobin > 9 g/dL Current use of an acceptable form of double-barrier birth control
Exclusion criteria
Exclusion criteria: Patients for whom, in the opinion of the investigator, their general status would not permit the administration of the study drugs or meet any of the study end points Patients with history of any other cancer including squamous NSCLC Patients who are taking other anti cancer agents Patients with other serious concomitant systemic disorder in addition to NSCLC that would make it difficult to complete the study at the discretion of the investigator Patients with any other major organ malfunction, including cardiac conditions and interstitial lung disease Patients with fluid retention â?? Pleural Effusion / Ascitis that cannot be controlled by drainage Patients with peripheral neuropathy >= Grade 1 as per National Cancer Institute Common Toxicity Criteria Patients with creatinine clearance of Patients with bilirubin > 1.5 times of the ULN Patients without hepatic metastases whose AST/ALT > 3.0 times the ULN Patients with hepatic metastases whose AST/ALT > 5.0 times the ULN Patients with active infection Patients with known history of HIV Patients hypersensitive to Pemetrexed or to any of the excipients Patients who are on non steroidal anti - inflammatory drugs (aspirin, ibuprofen, etc.) or may need to use them during the study Patients who may need concomitant administration of substances that are also tubular secreted (e.g., Probenecid) Patients with a life-expectancy of Female Patients who are pregnant / planning to become pregnant Patients who are Lactating mothers Inability of the patient and/or legally acceptable representative to give the informed consent Patients who are participating in another clinical trial currently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the bioequivalence of two pemetrexed formulations (Pemgem, Dr. Reddyâ??s Laboratories w.r.t Alimta, Eli Lilly) in adult chemo-naïve subjects of Adenocarcinoma-NSCLCTimepoint: 0hr,10 min,15 min,30 min,50 min,1 hr,1.20 hr,2.0 hr,4 hr,6 hr,8 hr,24 hr | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of the two formulations.Timepoint: day 1 | — |
Countries
India
Contacts
Public ContactVikram Gota
ACTREC, Tata Memorial Centre
Outcome results
None listed