NCT02171325

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

7 years

First QC Date

June 16, 2014

Last Update Submit

February 2, 2021

Conditions

Small Cell Lung Cancer

Keywords

irinotecanSmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Limiting Toxicity (DLT )in the irinotecan

    up to 18 weeks

Secondary Outcomes (1)

  • Maximum Tolerated Dose(MTD)in the irinotecan

    up to 18weeks

Study Arms (1)

irinotecan

EXPERIMENTAL

irinotecan； 60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2

Drug: irinotecan

Interventions

irinotecanDRUG

60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2

irinotecan

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65 years, male and female
  • Histologically or cytologically confirmed extensive stage .small cell lung cancer(SCLC )（except metastases only as pleural effusion）
  • No prior chemotherapy
  • Metastatic lesion had been treated more than 14 days by palliative radiation therapy or surgery
  • 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)
  • Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
  • Expected survival ≥ 3months
  • 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
  • +4 more criteria

You may not qualify if:

  • Patient have platinum compounds allergy history
  • Patient with active ulcer disease or chronic enteritis patients
  • Primary lesion(s) has (have) been treated by Surgery or radiation
  • Patient had received Immune drugs treatment for anti-lung cancer indications or anti-cancer Chinese traditional medicine treatment within two weeks
  • Patients with interstitial pneumonia or pulmonary fibrosis
  • Brain metastasis requiring treatment
  • Patient with bronchus or bronchial stenosis or blockage and superior vena cava syndrome caused by serious invasion
  • Patients with severe infections, severe abnormal secretion of (Anti Diuretic Hormone,ADH) syndrome, poorly controlled diabetes, severe complications requiring treatment vena cava syndrome
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jilin cancer hospital

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • ying cheng, doctor

    Jilin Provincial Tumor Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ying cheng, doctor

CONTACT

86-43185871902jl.cheng@163.com

qian liu, bachelor

CONTACT

86-43185873196xjy0202@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 24, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)