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

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.

Study Overview

• Status: Unknown
• Conditions: Small-cell Lung Cancer
• Intervention / Treatment: Drug: irinotecan plus lobaplatin; Drug: irinotecan

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ShengFa Su, PhD,MD; Phone Number: 0086-851-86513076; Email: sushengfa2005@163.com
• Study Contact Backup: Name: Bing Lu, MD; Email: 474111382@qq.com

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Recruiting
      • The Affiliated Hospital of Guizhou Medical University
      • Contact: Shengfa Su, PhD,MD; Phone Number: 86-13608550432; Email: sushengfa2005@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A; Chemotherapy:irinotecan plus lobaplatin	Drug: irinotecan plus lobaplatin; irinotecan plus lobaplatin chemotherapy
ACTIVE_COMPARATOR: Arm B; Chemotherapy:irinotecan	Drug: irinotecan; irinotecan chemotherapy alone

What is the study measuring?

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
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
Treatment toxicities	To assess and record nausea, vomiting, hematologic toxicity,and other treantment complications by CTCAE v4.0	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

Collaborators and Investigators

• Sponsor: ShengFa Su
• Investigators: Principal Investigator: ShengFa Su, PhD,MD, The Affiliated Hospital of Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: July 21, 2018
• First Submitted That Met QC Criteria: July 29, 2018
• First Posted (ACTUAL): August 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: relapsed
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: R-SCLC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No