Malignant Pleural EffusionPhase 2NCT02942043
Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer
A Phase 2 study testing Bevacizumab in people with Malignant Pleural Effusion, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of different doses of bevacizumab injection in the treatment of malignant pleural effusion in patients with advanced non-squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign informed consent;
- Non-squamous non-small cell lung cancer, newly diagnosed or previously treated with systemic chemotherapy and / or epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors treatment;
- B ultrasound, chest X-ray or CT examination to a large number of pleural effusion, with a cytology confirm of malignant pleural effusion;
- Aged 18-75 years;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
- Survival is expected to exceed 8 weeks
Who cannot join
- If any of the following criteria is met, the subject shall be excluded:
- Squamous cell carcinoma (including adenosquamous carcinoma) and small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer);
- In the past 2 weeks, there have been systematic anti-tumor treatment including chemotherapy (including thoracic chemotherapy), radiotherapy (excluding radiotherapy of metastatic lesions outside the thoracic radiation field), targeted therapy, immunotherapy and biotherapy;
- The subject had received anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks;
- The subject had participated any clinical trials in the past 4 weeks;
- The subject had previously received bevacizumab of pleural perfusion therapy;
Show all 32Show fewer
- Laboratory results:
- White blood cell count <3 × 109 / L, neutrophil count <1.5 × 109 / L, platelet <75 × 109 / L, or hemoglobin <8g / dL;
- Coagulation abnormalities (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time (APTT) > 1.5 ULN), with bleeding tendency or being treated with thrombolysis or anticoagulation;
- Serum total bilirubin ≥1.5 ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 ULN in the absence of liver metastases; ALT or AST ≥5 ULN in liver metastases;
- Serum albumin <30g / L;
- Serum creatinine ≥ 1.5 ULN or creatinine clearance <40ml / min;
- Urine routine urinary protein ≥ ++, or 24 hours urine protein ≥ 1.0 g;
- Hypertension cannot be controlled by drugs;
- Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure;
- Imaging (CT or MRI) showed a tumor lesion 5 mm away from the large vessels, or the presence of invasive central vasculature of the central tumor; imaging (CT or MRI) showed significant cavitation or necrosis of the lung tumor; Other diseases that may cause haemoptysis;
- Imaging (CT or chest radiograph) showed significant pneumothorax, fluid pneumothorax;
- Bilateral pleural cavity to a large number of effusion or encapsulated pleural effusion;
- Obvious cough blood in 6 months, or daily hemoptysis amounted to half a teaspoon (2.5ml) or more;
- Significant bleeding symptoms or with definite bleeding tendency within 12 months before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, occult blood ++ and above, intracerebral hemorrhage, vasculitis, or with congenital or acquired coagulopathy disorders;
- Thrombosis, cancer thrombosis (including arteriovenous thrombosis, tumor thrombus, pulmonary embolism, transient ischemic attack, etc.) occurred within 12 months;
- There are gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis and other gastrointestinal diseases or other diseases may cause gastrointestinal bleeding or perforation;
- Severe respiratory diseases, or need long-term oxygen, corticosteroid treatment of diseases such as chronic obstructive pulmonary disease, interstitial lung disease and respiratory failure;
- The toxicity of previous antineoplastic therapies has not yet recovered to below grade 2 or has not fully recovered;
- Patients with uncontrolled central nervous system metastasis;
- There are serious uncontrolled systemic diseases, such as nephrotic syndrome, infection, poorly controlled diabetes;
- Patients with active HIV（human immunodeficiency virus）, HBV（hepatitis B virus）, or HCV（hepatitis C virus） infection;
- Patients had undergone surgery (<28 days) or did not heal completely, or had other unhealed wounds before the study;
- Patients known to be allergic to bevacizumab or any of the components of the drug;
- Pregnant or lactating female patients, or unwilling to take contraceptive measures of reproductive age patients (including men);
- There is a serious psychological or mental abnormality, or lack of compliance;
- The investigator determines other circumstances that may affect the conduct of clinical studies and the determination of findings.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jian Fang, +86-010-88196459, bcht2_mj@163.com
Di Wu, +86-010-88196459, lucia8810@sina.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial of Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer
The purpose of this study is to explore the efficacy and safety of different doses of bevacizumab injection in the treatment of malignant pleural effusion in patients with advanced non-squamous non-small cell lung cancer.
Read the detailed description
This study is a prospective, multicenter, randomized, phase II clinical study. 87 patients will be recruited.
Group A (low dose group)
Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group B (medium dose group)
Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group C (high dose group)
Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Main evaluation criteria: pleural effusion objective response rate(ORR) (WHO standard)
Secondary evaluation criteria: pleural fluid time to progression (TTP), overall survival (OS), ORR, QOL scores (Quality of Life Questionnaire-lung cancer) and KPS, and safety (NCI CTCAE V4.03)
- Conditions
- Malignant Pleural Effusion
- Being tested
- Bevacizumab
- Keywords
- Malignant pleural effusion, Bevacizumab
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Group A (low dose group) Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group B (medium dose group) Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group C (high dose group) Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
| Study group | Role | What they receive |
|---|---|---|
| Group A (low dose group) | Experimental | Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. Receives: Drug: Bevacizumab |
| Group B (medium dose group) | Experimental | Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. Receives: Drug: Bevacizumab |
| Group C (high dose group) | Experimental | Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural effusion ORR
Measured: 1 year
Secondary outcomes (5)
Pleural fluid TTP
Measured: 1 year
OS
Measured: 1 year
ORR
Measured: 1 year
QOL scores
Measured: 2 month
Safety (NCI CTCAE V4.03)
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Fang, Peking University Cancer Hospital & Institute
- Investigators
- Jian Fang, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942043
- Sponsor's protocol ID
- 20160204
- Status last verified
- Nov 2018
- First submitted
- 18 Oct 2016
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Du N, Li X, Li F, Zhao H, Fan Z, Ma J, Fu Y, Kang H. Intrapleural combination therapy with bevacizumab and cisplatin for non-small cell lung cancer-mediated malignant pleural effusion. Oncol Rep. 2013 Jun;29(6):2332-40. doi: 10.3892/or.2013.2349. Epub 2013 Mar 15.
PubMed 23525453Medford AR, Maskell NA. A national survey of oncologist and chest physicians' attitudes towards empirical anti-oestrogen therapy, early pleurodesis and preference of sclerosing agent in malignant breast and ovarian pleural disease. Palliat Med. 2005 Jul;19(5):430-1. doi: 10.1191/0269216305pm1033xx. No abstract available.
PubMed 16111068Seto T, Ushijima S, Yamamoto H, Ito K, Araki J, Inoue Y, Semba H, Ichinose Y; Thoracic Oncology Group. Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in 80 patients with non-small-cell lung cancer: a multi-institutional phase II trial. Br J Cancer. 2006 Sep 18;95(6):717-21. doi: 10.1038/sj.bjc.6603319. Epub 2006 Aug 29.
PubMed 16940982Numnum TM, Rocconi RP, Whitworth J, Barnes MN. The use of bevacizumab to palliate symptomatic ascites in patients with refractory ovarian carcinoma. Gynecol Oncol. 2006 Sep;102(3):425-8. doi: 10.1016/j.ygyno.2006.05.018. Epub 2006 Jun 23.
PubMed 16797681Pichelmayer O, Gruenberger B, Zielinski C, Raderer M. Bevacizumab is active in malignant effusion. Ann Oncol. 2006 Dec;17(12):1853. doi: 10.1093/annonc/mdl143. Epub 2006 Jun 21. No abstract available.
PubMed 16790519Kesterson JP, Mhawech-Fauceglia P, Lele S. The use of bevacizumab in refractory ovarian granulosa-cell carcinoma with symptomatic relief of ascites: a case report. Gynecol Oncol. 2008 Dec;111(3):527-9. doi: 10.1016/j.ygyno.2008.07.015. Epub 2008 Aug 16.
PubMed 18710781Pichelmayer O, Zielinski C, Raderer M. Response of a nonmalignant pleural effusion to bevacizumab. N Engl J Med. 2005 Aug 18;353(7):740-1. doi: 10.1056/NEJM200508183530722. No abstract available.
PubMed 16107633Bae SH, Hwang JY, Kim WJ, Yoon HH, Kim JM, Nam YH, Baek HG, Cho YR, Park SY, Kim JH, Kim SH, Park TH, Lee GN, Rha SH, Kim YD. A case of cardiac amyloidosis with diuretic-refractory pleural effusions treated with bevacizumab. Korean Circ J. 2010 Dec;40(12):671-6. doi: 10.4070/kcj.2010.40.12.671. Epub 2010 Dec 31.
PubMed 21267391Kitamura K, Kubota K, Ando M, Takahashi S, Nishijima N, Sugano T, Toyokawa M, Miwa K, Kosaihira S, Noro R, Minegishi Y, Seike M, Yoshimura A, Gemma A. Bevacizumab plus chemotherapy for advanced non-squamous non-small-cell lung cancer with malignant pleural effusion. Cancer Chemother Pharmacol. 2013 Feb;71(2):457-61. doi: 10.1007/s00280-012-2026-4. Epub 2012 Nov 21.
PubMed 23178954Hama M, Komatsu Y, Hachiya T. [A case of lung cancer showing marked reduction of pleural effusion by bevacizumab in combination with carboplatin and paclitaxel]. Gan To Kagaku Ryoho. 2011 Nov;38(11):1877-9. Japanese.
PubMed 22083202Mitsuhiro Fuji, Shin-Ichiro Iwakami1, Hiroaki Ihara. Efficacy and safety of chemotherapy containing bevacizumab in patients with non-small cell lung cancer with malignant pleural effusion. Respirology. 2013;18 (Suppl.4): 87
Masago K, Fujimoto D, Fujita S, Hata A, Kaji R, Ohtsuka K, Okuda C, Takeshita J, Katakami N. Response to bevacizumab combination chemotherapy of malignant pleural effusions associated with non-squamous non-small-cell lung cancer. Mol Clin Oncol. 2015 Mar;3(2):415-419. doi: 10.3892/mco.2014.457. Epub 2014 Nov 19.
PubMed 25798278Tamiya M, Tamiya A, Yamadori T, Nakao K, Asami K, Yasue T, Otsuka T, Shiroyama T, Morishita N, Suzuki H, Okamoto N, Okishio K, Kawaguchi T, Atagi S, Kawase I, Hirashima T. Phase2 study of bevacizumab with carboplatin-paclitaxel for non-small cell lung cancer with malignant pleural effusion. Med Oncol. 2013;30(3):676. doi: 10.1007/s12032-013-0676-7. Epub 2013 Aug 8.
PubMed 23925664El-Shami K, Elsaid A, El-Kerm Y. Open-label safety and efficacy pilot trial of intraperitoneal bevacizumab as palliative treatment in refractory malignant ascites. J Clin Oncol.2007;25(18 suppl):9043
Hamilton CA, Maxwell GL, Chernofsky MR, Bernstein SA, Farley JH, Rose GS. Intraperitoneal bevacizumab for the palliation of malignant ascites in refractory ovarian cancer. Gynecol Oncol. 2008 Dec;111(3):530-2. doi: 10.1016/j.ygyno.2008.04.028. Epub 2008 Jun 18.
PubMed 18561992
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial of Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02942043
- Acronym / sponsor ID
- 20160204
- Conditions
- Malignant Pleural Effusion
- Keywords
- Malignant pleural effusion, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University Third Hospital
- Study start
- Oct 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the efficacy and safety of different doses of bevacizumab injection in the treatment of malignant pleural effusion in patients with advanced non-squamous non-small cell lung cancer.
Detailed description
This study is a prospective, multicenter, randomized, phase II clinical study. 87 patients will be recruited.
Group A (low dose group)
Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group B (medium dose group)
Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group C (high dose group)
Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Main evaluation criteria: pleural effusion objective response rate(ORR) (WHO standard)
Secondary evaluation criteria: pleural fluid time to progression (TTP), overall survival (OS), ORR, QOL scores (Quality of Life Questionnaire-lung cancer) and KPS, and safety (NCI CTCAE V4.03)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (low dose group) | Experimental | Drug: BevacizumabIntrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. |
| Group B (medium dose group) | Experimental | Drug: BevacizumabIntrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. |
| Group C (high dose group) | Experimental | Drug: BevacizumabIntrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign informed consent;
- Non-squamous non-small cell lung cancer, newly diagnosed or previously treated with systemic chemotherapy and / or epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors treatment;
- B ultrasound, chest X-ray or CT examination to a large number of pleural effusion, with a cytology confirm of malignant pleural effusion;
- Aged 18-75 years;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
Key exclusion criteria (32 listed)
- Squamous cell carcinoma (including adenosquamous carcinoma) and small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer);
- In the past 2 weeks, there have been systematic anti-tumor treatment including chemotherapy (including thoracic chemotherapy), radiotherapy (excluding radiotherapy of metastatic lesions outside the thoracic radiation field), targeted therapy, immunotherapy and biotherapy;
- The subject had received anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks;
- The subject had participated any clinical trials in the past 4 weeks;
- The subject had previously received bevacizumab of pleural perfusion therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinGroup A (low dose group) Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. Group B (medium dose group) Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. Group C (high dose group) Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard. | Drug | Group A (low dose group), Group B (medium dose group), Group C (high dose group) |
Primary outcome
Pleural effusion ORR
Time frame: 1 year
5 secondary outcomes
Pleural fluid TTP
Time frame: 1 year
OS
Time frame: 1 year
ORR
Time frame: 1 year
QOL scores
Time frame: 2 month
Safety (NCI CTCAE V4.03)
Time frame: 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 23525453Du N, Li X, Li F, Zhao H, Fan Z, Ma J, Fu Y, Kang H. Intrapleural combination therapy with bevacizumab and cisplatin for non-small cell lung cancer-mediated malignant pleural effusion. Oncol Rep. 2013 Jun;29(6):2332-40. doi: 10.3892/or.2013.2349. Epub 2013 Mar 15.
- Results publication: PubMed 16111068Medford AR, Maskell NA. A national survey of oncologist and chest physicians' attitudes towards empirical anti-oestrogen therapy, early pleurodesis and preference of sclerosing agent in malignant breast and ovarian pleural disease. Palliat Med. 2005 Jul;19(5):430-1. doi: 10.1191/0269216305pm1033xx. No abstract available.
- Results publication: PubMed 16940982Seto T, Ushijima S, Yamamoto H, Ito K, Araki J, Inoue Y, Semba H, Ichinose Y; Thoracic Oncology Group. Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in 80 patients with non-small-cell lung cancer: a multi-institutional phase II trial. Br J Cancer. 2006 Sep 18;95(6):717-21. doi: 10.1038/sj.bjc.6603319. Epub 2006 Aug 29.
- Results publication: PubMed 16797681Numnum TM, Rocconi RP, Whitworth J, Barnes MN. The use of bevacizumab to palliate symptomatic ascites in patients with refractory ovarian carcinoma. Gynecol Oncol. 2006 Sep;102(3):425-8. doi: 10.1016/j.ygyno.2006.05.018. Epub 2006 Jun 23.
- Results publication: PubMed 16790519Pichelmayer O, Gruenberger B, Zielinski C, Raderer M. Bevacizumab is active in malignant effusion. Ann Oncol. 2006 Dec;17(12):1853. doi: 10.1093/annonc/mdl143. Epub 2006 Jun 21. No abstract available.
- Results publication: PubMed 18710781Kesterson JP, Mhawech-Fauceglia P, Lele S. The use of bevacizumab in refractory ovarian granulosa-cell carcinoma with symptomatic relief of ascites: a case report. Gynecol Oncol. 2008 Dec;111(3):527-9. doi: 10.1016/j.ygyno.2008.07.015. Epub 2008 Aug 16.
- Results publication: PubMed 16107633Pichelmayer O, Zielinski C, Raderer M. Response of a nonmalignant pleural effusion to bevacizumab. N Engl J Med. 2005 Aug 18;353(7):740-1. doi: 10.1056/NEJM200508183530722. No abstract available.
- Results publication: PubMed 21267391Bae SH, Hwang JY, Kim WJ, Yoon HH, Kim JM, Nam YH, Baek HG, Cho YR, Park SY, Kim JH, Kim SH, Park TH, Lee GN, Rha SH, Kim YD. A case of cardiac amyloidosis with diuretic-refractory pleural effusions treated with bevacizumab. Korean Circ J. 2010 Dec;40(12):671-6. doi: 10.4070/kcj.2010.40.12.671. Epub 2010 Dec 31.
- Results publication: PubMed 23178954Kitamura K, Kubota K, Ando M, Takahashi S, Nishijima N, Sugano T, Toyokawa M, Miwa K, Kosaihira S, Noro R, Minegishi Y, Seike M, Yoshimura A, Gemma A. Bevacizumab plus chemotherapy for advanced non-squamous non-small-cell lung cancer with malignant pleural effusion. Cancer Chemother Pharmacol. 2013 Feb;71(2):457-61. doi: 10.1007/s00280-012-2026-4. Epub 2012 Nov 21.
- Results publication: PubMed 22083202Hama M, Komatsu Y, Hachiya T. [A case of lung cancer showing marked reduction of pleural effusion by bevacizumab in combination with carboplatin and paclitaxel]. Gan To Kagaku Ryoho. 2011 Nov;38(11):1877-9. Japanese.
- Results publicationMitsuhiro Fuji, Shin-Ichiro Iwakami1, Hiroaki Ihara. Efficacy and safety of chemotherapy containing bevacizumab in patients with non-small cell lung cancer with malignant pleural effusion. Respirology. 2013;18 (Suppl.4): 87
- Results publication: PubMed 25798278Masago K, Fujimoto D, Fujita S, Hata A, Kaji R, Ohtsuka K, Okuda C, Takeshita J, Katakami N. Response to bevacizumab combination chemotherapy of malignant pleural effusions associated with non-squamous non-small-cell lung cancer. Mol Clin Oncol. 2015 Mar;3(2):415-419. doi: 10.3892/mco.2014.457. Epub 2014 Nov 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Fang principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Malignant Pleural Effusion, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Fang (+86-010-88196459, bcht2_mj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleural effusion ORR (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02942043, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.