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Trial record 6 of 42 for:    Malignant Hyperthermia 5

Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy

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ClinicalTrials.gov Identifier: NCT01838538
Recruitment Status : Unknown
Verified April 2013 by DuNan, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : April 24, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
DuNan, Chinese PLA General Hospital

Brief Summary:
To study the efficacy and safety of intraperitoneal injection bevacizumab combined with intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of ovarian cancer. To analyze the clinical significance of the concentration change of vascular endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection bevacizumab

Condition or disease Intervention/treatment Phase
Ovarian Cancer With Malignant Ascites Drug: Bevacizumab Drug: TC:paclitaxel + carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2011
Estimated Primary Completion Date : June 2013


Arm Intervention/treatment
Experimental: Bevacizumab+TC
The treatment group were accepted intraperitoneal injection with bevacizumab (avastin) 300mg after each intraperitoneal hyperthermic perfusion chemotherapy for 6 weeks.
Drug: Bevacizumab
Drug: TC:paclitaxel + carboplatin
Active Comparator: TC
patients were treated with TC chemotherapy (paclitaxel 135mg/m2 ,iv d1+ carboplatin AUC=5, iv d1), 1 time/3 weeks for 6 weeks, and with intraperitoneal hyperthermic perfusion chemotherapy combined with intraperitoneal cisplatin 40mg/m2,1 time/2 weeks for 6 weeks
Drug: TC:paclitaxel + carboplatin



Primary Outcome Measures :
  1. objective response rate [ Time Frame: 24month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
  • Histologically confirmed and documented ovarian cancer with malignant ascites.
  • ECOG(Eastern Cooperative Oncology Group, ECOG) PS 0-2.
  • Life expectancy of >3 months.
  • No serious inadequate bone marrow function, liver and renal function or significant cardiovascular disease.

Exclusion Criteria:

  • Known hypersensitivity to any of the study drugs or excipients.
  • Any current anti-cancer therapy.
  • No evidence of ascites.
  • Key organ dysfunction.
  • Significant cardiovascular disease (e.g. congestive heart failure (CHF), uncontrolled cardiac arrhythmia, angina, heart valve disease, myocardial infarction and refractory hypertension need to be long time controlled by medicine).
  • Non-healing wound, ulcer or bone fracture.
  • Uncontrolled psychiatric history.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838538


Contacts
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Contact: Nan Du, PhD 861068989123 dunan05@yahoo.com.cn
Contact: Jihua Chen, MD 862128922576 jihua.chen@roche.com

Locations
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China, Beijing
First Hospital Affiliated to the PLA General Hospital, Beijing,China Recruiting
Beijing, Beijing, China, 100048
Contact: Nan Du, PhD    861068989123    dunan05@yahoo.com.cn   
Principal Investigator: Hui Zhao, PhD         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Zhao Hui, PhD Chinese PLA General Hospital

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Responsible Party: DuNan, Chief Physician, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01838538     History of Changes
Other Study ID Numbers: ML25396
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Ascites
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances