CBDCA, PTX and BV for NSCLC (non-sq) with IP

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs061180046
• Date of registration: 12/03/2019
• Prospective Registration: No
• Primary sponsor: Katakami Nobuyuki
• Public title: CBDCA, PTX and BV for NSCLC (non-sq) with IP
• Scientific title: Phase II study of carboplatin, weekly paclitaxel and bevacizumab for advanced non-squamous cell, non-small-cell lung cancer with idiopathic interstitial pneumonia - IP002
• Date of first enrolment: 17/01/2013
• Target sample size: 35
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs061180046
• Study type: Interventional
• Study design: single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose
• Phase: 2

Contacts

• Name: Akito Hata
• Affiliation: Kobe Minimally invasive Cancer Center

• Name: Nobuyuki Katakami
• Affiliation: Takarazuka City Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1)Non-squamous, non-small cell lung cancer
2)No prior radiotherapy to primary tumor
3)Age over twenty
4)Idiopathic interstitial pneumonia
5)Measurable lesion
6)The following procedures or operations should be completed before protocol treatment
1.major surgery (including exploratory thoracotomy): more than 4 weeks
2.chest tube drainage: more than 2 weeks
3.incisional biopsy or treatment of injury: more than 2 weeks
4.bronchoscopic tumor biopsy, bronchoscopic needle aspiration biopsy, or implantation of central venous port: more than 1 week.
7) ECOG performance status 0 or 1
8) Adequate organ function
WBC>=3000/mm3 and neutrophil count >=2000/mm3
Hgb>=10.0g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL, proteinuria=<1+, or =< 2g/day
9) PaO2>=60.0 torr or SpO2>=92.0 % (room air)
10) Life expectancy >= 3 months
11) Written informed consent
Exclusion criteria: 1) Secondly interstitial pneumonia.
2) History of acute exacerbation of interstitial pneumonia within 3 months.
3) Subacute progression of interstitial pneumonia within 3 months.
4) Using prednisolone or immune-suppressive agent.
5) Need to home oxygen therapy.
6) Past history of severe drug allergy.
7) Active infectious disease.
8) Severe complications.
9) Symptomatic brain metastasis.
10) Uncontrollable effusion.
11) Hemoptysis.
12) Apparent invasion into great vessels, apparent pulmonary cavitary lesion.
13) Active peptic ulcer.
14) Bleeding tendency.
15) Unhealed major operation wounds.
16) Thrombosis.
17) Multiple primary cancers with disease-free period less than 2 years, except carcinoma in situ or intra mucosal disease cured by local therapy.
18) Any ineligible case judged by physician.

Age minimum: >= 20age old
Age maximum: Not applicable
Gender: Both

Health Condition(s) or Problem(s) studied

Non-squamous, non-small cell lung cancer
Lung cancer

Lung cancer

Intervention(s)

Carboplatin (AUC=5) given on day1, paclitaxel (70mg/m2) given on days 1,8,15 and bevacizumab (15mg/m2) on day 1 every 4weeks until disease progression or unmanageable toxicity.

Primary Outcome(s)

Response rate

Secondary Outcome(s)

overall survival, progression free survival,
time to treatment failure, adverse event

Secondary ID(s)

UMIN000018322

Source(s) of Monetary Support

Takarazuka City Hospital

Kobe City Medical Center General Hospital

Ethics review

Status: Approval
Approval date: 28/01/2019
Contact:

[e-mail]

Shimane University Hospital, Clinical Trial Review Board

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 20/10/2021
• Date Completed: 19/10/2020