UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005872
Receipt number R000006905
Scientific Title A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)
Date of disclosure of the study information 2011/06/28
Last modified on 2017/01/04 13:10:34

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Basic information

Public title

A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)

Acronym

A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)

Scientific Title

A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)

Scientific Title:Acronym

A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the efficacy and safety of maintenance Bevacizumab+Erlotinib following Carboplatin+Pemetrexed+Bevacizumab
with Non-squarmous Non-small-cell lung cancer not harboring EGFR mutations for
patient

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression-free survival at 6 months

Key secondary outcomes

Response rate
Shift ratio to maintenance therapy
Overall survival
Safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pemetrexed+Carboplatin+Bevacizumab followed by maintenance Erlotinib+Bevacizumab until disease progression

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)Age: 20-74 years
2)Histologically or cytrologically confirmed diagnosis of non-squamous non-small cell lung cancer (non-squamous NSCLC).
3)Stage IIIB/IV or postoperative recurrence
4)No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last administration of adjuvant chemotherapy.
5)Patients who have measurable lesions.
6)Eastern Cooperative Oncology Group
(ECOG) Performance status of 0-2.
7)Adequate function of main organ.
White blood cell count>=3000/mm3
Absolute granulocyte count >= 1500/mm3
Hemoglobin >= 9.0g/dL
Platelet count >= 100,000/mm3
Serum bilirubin <= 1.5 mg/dL
AST,ALT <100 IU/l
Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min
PaO2(Room air) >=60Torr (or SpO2>=95%)
Proteinuria<1+
8)Life expectancy more than 3 months
9)Written informed consent

Key exclusion criteria

1)Previous histories of drug allergy, which may increase the risk of this study.
2)Serious concomitant infection.
3)Usages of oral steroids or immunosuppressive drugs.
4)Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes.
5)Interstitial pneumonia or pulmonary fibrosis on chest CT scans.
6)Patients with EGFR mutation.
7)Severe pleural, abdominal or cardiac effusion.
8)Prior to study entry major surgical procedures within 3 weeks or prior systemic therapy to contain radiotherapy within 2 weeks.
9)Patient in acknowledgment of hemoptysis (2.5 ml or more) or clinically important bleeding or a clot-related event.
10)No uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 90 mmHg).
11)Symptomatic brain metastasis.
12)The patient that the tumor permeation to chest great vessels is accepted.
13)cavity in tumor.
14)receiving anticoagulant drug(except Aspirin under 325mg/day).
15)Patients with active concomitant malignancy.
16)Pregnant, lactating women.
17)Inappropriate patients judged by physicians.

Target sample size

51


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Oizumi

Organization

Hokkaido University

Division name

First Department of Medicine

Zip code


Address

North 15,West7, Kita-ku, Sapporo 060-8638, Japan

TEL

011-706-5911

Email

soizumi@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriyuki Yamada

Organization

Hokkaido University

Division name

First Department of Medicine

Zip code


Address

North 15,West7, Kita-ku, Sapporo060-8638, Japan

TEL

011-706-5911

Homepage URL


Email

ymda3nr222@gmail.com


Sponsor or person

Institute

Hokkaido Lung Cancer Clinical Study Group

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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 06 Month 28 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 06 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 06 Month 28 Day

Last modified on

2017 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006905


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name