Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment

A Phase Ⅱ Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment

The purpose of this study is to identify the appropriate dose of irinotecan by dose escalation(dose climbing) test. The study would provide rationale for regimen decision in a future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be selected as therapeutic drugs.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: irinotecan

Detailed Description

To determine the Maximum Tolerated Dose (MTD) and Limiting Toxicity (DLTs) of irinotecan in patients with extensive stage small cell lung cancer treated with irinotecan plus cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • Jilin cancer hospital
      • Contact: ying cheng, doctor; Phone Number: 86-43185871902; Email: jl.cheng@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 to 65 years, male and female
2. Histologically or cytologically confirmed extensive stage .small cell lung cancer(SCLC )（except metastases only as pleural effusion）
3. No prior chemotherapy
4. Metastatic lesion had been treated more than 14 days by palliative radiation therapy or surgery
5. With measurable tumor lesions (Non-irradiated parts),(RECIST 1.1: Without radiotherapy ,the longest diameter is more than 10mm by CT or MRI ,except that lymph nodes need short diameter need more then 15mm, and the lesions can be accurately evaluated repeatedly measurable)
6. Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
7. Expected survival ≥ 3months

8. Marrow,kidney, liver,heart and lung are well -functioning,and absolute count of

   • absolute neutrophil coun(ANC) ≥ 2.0 × 109 / L
   • blood platelet(PLT) ≥ 100 × 109 / L
   • Hb≥ 90g / L
   • conjugative bilirubin(CB)≤ upper limit of normal(ULN) × 1.5
   • Aspartate transaminase(AST )(glutamic oxalacetic transaminase,GOT): ≤ upper limit of normal(ULN )× 2.5
   • Alanine aminotransferase(ALT)(Glutamate Pyruvate Transaminase,GPT): ≤ ULN × 2.5
   • Serum creatinine: ≤ ULN or calculated creatinine clearance≥ 60 ml / min
   • (PT INR) ≤ ULN × 1.5
   • ECG: no abnormalities in need of treatment
9. No pregnancy or no pregnancy demand at the end of the study within six months
10. Must provide written informed consent.

Exclusion Criteria:

1. Patient have platinum compounds allergy history
2. Patient with active ulcer disease or chronic enteritis patients
3. Primary lesion(s) has (have) been treated by Surgery or radiation
4. Patient had received Immune drugs treatment for anti-lung cancer indications or anti-cancer Chinese traditional medicine treatment within two weeks
5. Patients with interstitial pneumonia or pulmonary fibrosis
6. Brain metastasis requiring treatment
7. Patient with bronchus or bronchial stenosis or blockage and superior vena cava syndrome caused by serious invasion
8. Patients with severe infections, severe abnormal secretion of (Anti Diuretic Hormone,ADH) syndrome, poorly controlled diabetes, severe complications requiring treatment vena cava syndrome
9. Severe cardiovascular disease: hypertension that medical treatment can not be controlled , unstable angina, myocardial infarction within the last June a history of congestive heart failure> 3 (NYHA) and severe arrhythmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: irinotecan; irinotecan； 60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2	Drug: irinotecan; 60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Limiting Toxicity (DLT )in the irinotecan	up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Tolerated Dose(MTD)in the irinotecan	up to 18weeks

Collaborators and Investigators

• Sponsor: Guangdong Association of Clinical Trials
• Investigators: Principal Investigator: ying cheng, doctor, Jilin Provincial Tumor Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: irinotecan; Small Cell Lung Cancer
• 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: CTONG1402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO