To compare the blood levels of Pemetrexed in Non small cell lung cancer patients treated with Alimta and Pemgem

Not Applicable

• Conditions: Health Condition 1: null- Indian adult ChemoNaive Adenocarcinoma Non-small cell lung cancer patient

• Registration Number: CTRI/2012/09/002972
• Lead Sponsor: INVESTIGATOR INITIATED TRIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 40

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 < 25% of bone marrow whole pelvis not allowed

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

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 < 45mL/min as calculated by the modified Cockfort and Gault lean body mass formula

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 < 6 months as per the investigatorâ??s discretion

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

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the safety and tolerability of the two formulations.Timepoint: day 1