A Randomized study comparing Weekly Paclitaxel plus Best Supportive Care with Best Supportive Care Alone in Patients with small cell lung cancer relapsed on two or more lines of chemotherapy.

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•1.Histologically or cytologically proven SCLC
•2.Age over 18 years
•3.Patient should have received at least two lines of systemic therapy and therapy should have been stopped due to progressive disease or intolerable side-effects. Chemotherapy received concurrently with radiotherapy may be considered as one line of systemic therapy.
•4.Eastern cooperative oncology group (ECOG) performance status < 2
•5.Willing to provide written, informed consent.
•6.Baseline laboratory parameters within acceptable limits, including
•a.Hemoglobin > 8 g/dl
•b.Absolute neutrophil count > 1.5 x 10e9/L and total leucocyte counts > 3.5 x 10e9/L
•c.Baseline liver function tests:
•i.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN)
•ii.Total bilirubin levels < 1.5 times ULN
•iii.In patients with liver metastases, transaminases (AST and ALT) should be < 5 times ULN and bilirubin < 3 times ULN.
•d.No contraindications to receiving chemotherapy.

•1.Serious co-morbidities such as, but not limited to severe cardiac failure or severe pulmonary compromise or severe and active infections.
•2.Peripheral neuropathy > grade 2.
•3.Patient has received paclitaxel chemotherapy.
•4.Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable.
•5.Patients on other investigational drugs within the last 30 days.
•6.Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

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