Phase II Trial of BK-UM against HB-EGF in combination with Gemcitabine in Patients with advanced or recurrent ovarian cancer

Phase 2

• Conditions: Patients with advanced or recurrent ovarian cancer (include fallopian tube cancer and peritoneal cancer)

• Registration Number: JPRN-UMIN000009923
• Lead Sponsor: Osaka University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patient who have metastasis except for abdominal cavity or have the liver metastasis. 2)Patients who have serious illness or suspect to have serious illness mentioned below. 1.Patients with coronary heart disease or arrhythmia to need treatment. 2.Patient with left ventricle ejection fraction less than 50% in echocardiogram. 3.Patients who have cardiac dysfunction as grade III or IV of NYHA or have cardiac infarction within 6 months. 4. patient with pulmonary embolism. 5.Patients with decompensated cirrhosis. 6.Patients with interstitial pneumonia or pulmonary fibrosis, that is confirmed by chest X-ray and is associated with clinical symptoms. 7.The patients who need psychotic therapy or who take psychiatric medication. 8.Patients with poorly-controlled diabetes. 9.Patients with ileus or subileus. 10.Patients with active or poorly-controlled serious infection. 11.Patients with myelosuppression. 3)Patients with serious drug hypersensitivity. 4)Pregnant women, nursing mothers, or patients with chance of pregnancy. 5)Patients with a history of antiserum use. 6)Patient with multiple malignancies or with those history 5 years before agreement. 7)The patient who have a history of deferred treatment more than 6 weeks by hematotoxicity caused by the taxanes or the platinums use. 8)Patients who received the investigational drug 4 weeks before agreement. 9)Patients with a history of BK-UM use. 10)Patients undergoing radiation therapy to chest. 11)The patient that principal investigator or sub investigators judged the participation in this clinical trial to be inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
1) observation of curative effect 2) Exploration of biomarker predicting curative effect 3) Plasma CRM197 concentration, plasma gemcitabine concentration (confirmation of the accumulation)