UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006497
Receipt No. R000007605
Scientific Title A phase II trial of sequential treatment from cisplatin-etoposide therapy (PE) to irinotecan hydrochloride + amrubicin hydrochloride therapy with concomitant use of G-CSF nartograstim in patients with extensive-stage small cell lung cancer or advanced large cell neuroendocrine carcinoma (LCNEC)
Date of disclosure of the study information 2011/10/07
Last modified on 2011/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A phase II trial of sequential treatment from cisplatin-etoposide therapy (PE) to irinotecan hydrochloride + amrubicin hydrochloride therapy with concomitant use of G-CSF nartograstim in patients with extensive-stage small cell lung cancer or advanced large cell neuroendocrine carcinoma (LCNEC)
Acronym Investigational study on the efficacy and safety of sequential treatment from PE therapy to CPT + AMR combination therapy with concomitant use of NUP in patients with extensive small cell lung cancer or stage IIIB/IV large cell neuroendocrine carcinoma
Scientific Title A phase II trial of sequential treatment from cisplatin-etoposide therapy (PE) to irinotecan hydrochloride + amrubicin hydrochloride therapy with concomitant use of G-CSF nartograstim in patients with extensive-stage small cell lung cancer or advanced large cell neuroendocrine carcinoma (LCNEC)
Scientific Title:Acronym Investigational study on the efficacy and safety of sequential treatment from PE therapy to CPT + AMR combination therapy with concomitant use of NUP in patients with extensive small cell lung cancer or stage IIIB/IV large cell neuroendocrine carcinoma
Region
Japan

Condition
Condition Extensive-stage small cell lung cancer and stage IIIB/IV large cell neuroendocrine carcinoma (LCNEC)
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of sequential treatment from PE therapy (cisplatin [CDDP] + etoposide [VP-16]) to CAN therapy (irinotecan hydrochloride [CPT-11] + amrubicin hydrochloride [AMR]) with concomitant use of granulocyte colony-stimulating factor nartograstim (NUP) in patients with extensive-stage small cell lung cancer or stage IIIB/IV large cell neuroendocrine carcinoma (LCNEC)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Step 1: Tolerability
Step 2: Response rate
Key secondary outcomes Antitumor effect, survival, and safety (type, frequency, and grade of side effects)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PE therapy:
CDDP 80 mg/m2 on day 1
VP-16 100 mg/m2 on days 1-3
Three to four week treatment constitutes one course.

CAN therapy:
CPT-11 60 mg/m2 on days 1 and 8
AMR 35 mg/m2 on days 1-3
Nartograstim 1ug/kg/day on days 4-15 except on day 8.
Three to four week treatment constitutes one course.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Confirmed small cell lung cancer and/or large cell neuroendocrine carcinoma (LCNEC) based on histological or cytological examination
2) Curative radiation therapy-naive extensive disease or stage IIIB/IV large cell neuroendocrine carcinoma (LCNEC)
3) No prior chemotherapy; however, treatment with biological response modifier (BRM) for pleural effusion management allowed if performed 14 days or more prior to enrollment. No prior radiotherapy and/or surgical treatment for the primary lesion of lung carcinoma; however, radiotherapy for other than primary lesions, thorax, and ilium allowed if performed 28 days or more prior to enrollment.
4) Age 75 years or younger at enrollment
5) Expected survival <= 8 weeks
6) ECOG performance status (PS) 0-2
7) No significant injury to key organs including bone marrow, heart, lung, liver, and kidney, etc., with laboratory values meeting all of the following:
1. White blood cell count <= 4,000/mm3 and >= 12,000 mm3
2. Platelet count <= 100,000/mm3
3. Hemoglobin <= 9.0 g/dL
4. AST (GOT) and ALT (GPT) >= 100 IU/L; however, up to 300 IU/L allowed in cases of liver metastasis.
5. Total bilirubin >= 2.0 mg/dL
6. Serum creatinine >= 1.5 mg/dL
7. Creatinine clearance <= 60 ml/min
8. PaO2 <= 60 torr
9. No abnormalities which require treatment with electrocardiogram

8) Sufficient explanation about the contents of the trial, followed by written informed consent by the participant in person prior to enrollment
Key exclusion criteria 1) Superior vena cava syndrome
2) History of severe drug allergy
3) Large pleural effusion, ascites, and/or cardiac effusion
4) Clinically relevant infectious disease
5) Diarrhea (watery diarrhea)
6) Intestinal paralysis and/or ileus
7) Obvious interstitial pneumonia and/or pulmonary fibrosis based on chest X-ray
8) Brain metastasis with any symptoms; however, asymptomatic patients may be enrolled if symptoms are resolved after radiotherapy, not steroid therapy.
9) Simultaneously active double cancer*1
10) Uncontrollable diabetic disease
11) Clinically relevant cardiac diseases*2
12) Patients judged to be difficult to participate in the trial due to a clinically relevant neuropsychiatric disorder, etc.
13) Pregnant or lactating women, or those who may become pregnant or who have no intention of contraception
14) Patients whose participation in the trial was judged to be inappropriate due to safety reasons by investigators, etc.

*1Double cancer comprises simultaneous double cancer and metachronous double cancer with a disease-free interval of 5 years or shorter. However, active double cancer does not include in-situ carcinoma or intramucosal carcinoma judged to be recovered by local treatment.

*2These include congestive cardiac failure, symptomatic coronary artery disease, uncontrollable arrhythmia, and myocardial infarction occurring within preceding 6 months.
Target sample size 31

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Masuda
Organization Kitasato University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-15-1 Kitasato Minami-Ku, Sagamihara Kanagawa
TEL 042-778-9371
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sakiko Ootani
Organization Kitasato University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 1-15-1 Kitasato Minami-Ku, Sagamihara Kanagawa
TEL 042-778-9371
Homepage URL
Email

Sponsor
Institute Department of Respiratory Medicine
Kitasato University School of Medicine
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2011 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 06 Day
Last modified on
2011 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007605

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.