Small-cell Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer
This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent small-cell lung cancer.
The most widely applied first-line treatment mode for small-cell lung cancer (SCLC) patients
was chemotherapy as initial treatment. Etoposide with cisplatin or carboplatin were
considered the standard first-line regimen in SCLC. As for second-line chemotherapy, single
regimen irinotecan or a combined regimen containing irinotecan were one of preferred regiems.
While there still is no consensus on second-line therapy. Clinical studies have demonstrated
that the combination of irinotecan and carboplatin or cisplatin did not improve outcome in
recurrent SCLC patients compared with irinotecan alone. One of the main reasons is that
carboplatin or cisplatin has been used in the first-line treatment, and SCLC showed
cross-resistance to carboplatin and cisplatin.
Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA
Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum
antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test
tumor models, which overcomes some forms of cisplatin or carboplatin resistance in
preclinical tumour models. Retrospective studies also have demonstrated the efficacy of
Lobaplatin in patients with relapsed SCLC. Thus, we perform this randomized study to compare
the efficacy and safety of irinotecan plus lobaplatin versus irinotecan in patients recurrent
SCLC.
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