RecruitingACTRN12611000013965

Inter-ethnic differences in tolerance of anti-cancer drugs in non-small cell lung cancer patients

Exploration of differences in tolerance between Caucasian and Asian non-small cell lung cancer patients receiving palliative chemotherapy with carboplatin and paclitaxel


Sponsor

Sydney Cancer Centre

Enrollment

120 participants

Start Date

Jan 24, 2007

Study Type

Observational

Conditions

Summary

Recent evidence shows an ethnic variability in tolerance of anticancer drugs between Asian and Caucasian non-small cell lung cancer patients. Pharmacogenetic differences in drug metabolising enzymes have been proposed as the cause of these differences, however they have not been associated with altered cytotoxic drug pharmacokinetics (PK). Other possible explanations include differences in dietary/concomitant medicine intake and inflammatory status. The aim of this study was to investigate inter-ethnic differences in cytotoxic drug metabolism, inflammatory/nutritional status, genotype and outcomes between Asian and Caucasian non-small cell lung cancer patients.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Doctors have noticed that Asian and Caucasian patients with non-small cell lung cancer (a type of lung cancer) seem to have different side effects and tolerances when taking the same chemotherapy drugs. This study is trying to understand why. Researchers are comparing how patients from different ethnic backgrounds process the chemotherapy drugs carboplatin and paclitaxel. They are looking at differences in the immune system, nutrition levels, genetics, and other factors to see what might explain these differences. You may be eligible if: - You are 18 years or older - You identify as Asian or Caucasian - You have been diagnosed with advanced non-small cell lung cancer (confirmed by a tissue sample) - You are being treated with carboplatin and paclitaxel chemotherapy - Your overall health level is good enough to tolerate treatment (ECOG performance status 0–2) - Your blood counts and organ function are within acceptable ranges You may NOT be eligible if: - You need your chemotherapy dose adjusted for reasons other than standard protocols - You have active cancer spread to the brain - You have bone marrow involvement from the cancer - You have a serious active infection or autoimmune disease - You are on long-term steroids or immune-suppressing medications - You have had chemotherapy within the past 4 weeks - You have another active cancer - You are allergic to any of the chemotherapy drugs in this study Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Observe side effects, nutritional status, inflammatory factors and measure drug clearance of the cycle 1 treatment (21 days): Paclitaxel 175 mg/m2 in 3 hour intravenous infusion, day 0 Carboplatin A

Observe side effects, nutritional status, inflammatory factors and measure drug clearance of the cycle 1 treatment (21 days): Paclitaxel 175 mg/m2 in 3 hour intravenous infusion, day 0 Carboplatin AUC 6 in 1 hour intravenous infusion, day 0 Collect Deoxyribonucleic acid (DNA) samples for pharmacogenomics purpose Toxicity observation is implemented during the first cycle only, response observation is implemented after 3 cycles. Patients recruited over 5 years.


Locations(1)

Shanghai, China

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ACTRN12611000013965