UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Step 1: Tolerability
Step 2: Response rate

Key secondary outcomes

Antitumor effect, survival, and safety (type, frequency, and grade of side effects)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Respiratory Medicine
Kitasato University School of Medicine

Institute

Department

Personal name

Organization

no

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

10

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

10

Month

06

Day

Last modified on

2011

Year

10

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007605