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

NCT ID: NCT03613753

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-06-01

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.

Conditions

Small-cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Chemotherapy:irinotecan plus lobaplatin

Group Type: EXPERIMENTAL

irinotecan plus lobaplatin

Intervention Type: DRUG

irinotecan plus lobaplatin chemotherapy

Arm B

Chemotherapy:irinotecan

Group Type: ACTIVE_COMPARATOR

irinotecan

Intervention Type: DRUG

irinotecan chemotherapy alone

Interventions

irinotecan plus lobaplatin

irinotecan plus lobaplatin chemotherapy

Intervention Type: DRUG

irinotecan

irinotecan chemotherapy alone

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ShengFa Su

OTHER

Sponsor Role: lead

Responsible Party

ShengFa Su

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

ShengFa Su, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital Of Guizhou Medical University

Locations

The affiliated hospital of Guizhou medical university

Guiyang, Guizhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

ShengFa Su, PhD,MD

Role: CONTACT

sushengfa2005@163.com

0086-851-86513076

Bing Lu, MD

Role: CONTACT

474111382@qq.com

Facility Contacts

Shengfa Su, PhD,MD

Role: primary

sushengfa2005@163.com

86-13608550432

Other Identifiers

R-SCLC-001

Identifier Type: -

Identifier Source: org_study_id