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Status unknownNCT02171325Updated Feb 3, 2021

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

A Phase 2 interventional study of irinotecan in Small Cell Lung Cancer, sponsored by Guangdong Association of Clinical Trials. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Guangdong Association of Clinical Trials · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Small Cell Lung Cancer

Keywords

  • irinotecan
  • Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 54 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Guangdong Association of Clinical Trials is the lead sponsor of 53 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    irinotecan

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

    Drug: irinotecan

Interventions

  • Drugirinotecan

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

06

What researchers measure

Primary outcomes

  1. Limiting Toxicity (DLT )in the irinotecan

    Time frame: up to 18 weeks

Secondary outcomes

  1. Maximum Tolerated Dose(MTD)in the irinotecan

    Time frame: up to 18weeks

07

Study locations

1 of 1 sites recruiting
  • Jilin cancer hospital
    Changchun, Jilin 130000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02171325
Lead sponsor
Guangdong Association of Clinical Trials
Responsible party
Sponsor
First posted
Jun 24, 2014
Start date
Jun 2014
Primary completion
Jun 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Feb 3, 2021

Study contacts

ying cheng, doctor
Contact
jl.cheng@163.com
86-43185871902
qian liu, bachelor
Contact
xjy0202@163.com
86-43185873196
ying cheng, doctor
principal investigator · Jilin Provincial Tumor Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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