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

February 2, 2021 updated by: Guangdong Association of Clinical Trials

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: qian liu, bachelor
  • Phone Number: 86-43185873196
  • Email: xjy0202@163.com

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: up to 18 weeks
up to 18 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Association of Clinical Trials

Investigators

  • Principal Investigator: ying cheng, doctor, Jilin Provincial Tumor Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTONG1402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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