Irinotecan Plus Lobaplatin Versus Irinotecan in the Second-line Treatment of Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer

Conditions
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Small-cell Lung Cancer

Intervention / Treatment
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* Drug: irinotecan plus lobaplatin
* Drug: irinotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relapsed SCLC Etoposide with cisplatin or carboplatin was first-line chemotherapy in SCLC At least 30 days after the completion of first-line chemotherapy Either sex, age between 18 to 70 years Expected life time ≥ 3 months Performance status ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded. Adequate bone marrow and organ function as defined below: Neutrophils ≥ 1.5 × 109/L, platelets 80 × 109/L, hemoglobin ≥80 g/L; AST and ALT ≤2× the upper limit of the institutional normal range, total bilirubin ≤1.25× the upper limit of the institutional normal range; Creatinineconcentration ≤120 μmol/L Had measurable or assessable disease Exclusion Criteria: Concomitant with other malignant disease Pregnancy or lactation at the time of enrollment Any contraindications for chemotherapy Received target therapy or immunotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Chemotherapy:irinotecan plus lobaplatin | Drug: irinotecan plus lobaplatin<br>* irinotecan plus lobaplatin chemotherapy<br>|
| Active Comparator: Arm B<br>Chemotherapy:irinotecan | Drug: irinotecan<br>* irinotecan chemotherapy alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Tumor Response will be evaluated using the RECIST 1.1 criteria.ORR is Partial response (PR) and complete response (CR). | >4 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment toxicities | To assess and record nausea, vomiting, hematologic toxicity,and other treantment complications by CTCAE v4.0 | up to 12 months | 
| Progression-free survival(PFS) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. | up to 12 months | 
| Overall survival(OS) | Overall survival is defined as the time interval from date of diagnosis to date of death from any cause | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed