Clinical trial NCT03613753: Irinotecan Plus Lobaplatin Versus Irinotecan in the Second-line Treatment of Small Cell Lung Cancer
Official title: A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small-cell Lung Cancer
Keywords: relapsed
Lead sponsor: Guizhou Medical University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: >4 weeks post treatment
Secondary outcomes:
measure: Treatment toxicities
timeFrame: up to 12 months
measure: Progression-free survival(PFS)
timeFrame: up to 12 months
measure: Overall survival(OS)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The affiliated hospital of Guizhou medical university
state: Guizhou
Study officials:
affiliation: The Affiliated Hospital Of Guizhou Medical University
name: ShengFa Su, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: