A phase 2 trial of Gemcitabine+Cisplatin+Bevacizumab regimen for the patients with first recurrence or refractory of ovarian clear cell carcinoma KCOG-G1601

Phase 2

• Conditions: first recurrent or refractory of ovarian clear cell carcinoma

• Registration Number: JPRN-UMIN000023097
• Lead Sponsor: Kansai clinical oncology group(KCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-11
• Study Completion: 2021-12-31
• Results First Posted: 2022-12-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patient is contraincicated for use in gemcitabine,cisplatin and bevacizumab 2)Patient with uncontrolled heart disease,renal disease and diabetes mellitus 3)Patient with interstitial pneumonia or lung fibrosis 4)Patient with paresis of intestine or ileus 5)Patient with active infection 6)Patient who had chest and abdominal radiation therapy prior to registration 7)Patient with active other malignancy,excluded carcinoma in situ 8)Patient with history of severe drug allergy 9)Patient with obstructive bowel disease,diverticular perforation,intestinal fistula,perforation of the digestive tract,intraperitoneal abscess and Patient with intestinal invasion or ileus confirmed by pelvic examination or CT 10)Patient who have central nerve metastasis with symptom 11)Patient with pregnancy or breast-feeding,Patient who has possibility of pregnancy,notwilling to contraception 12)the following patient 1.Patient with arterial thrombosis or venous thrombosis,included cerebrovascular disorder,stroke,transient ischemic attack or subarachnoid bleeding within 6 months prior to this treatment,but history of arterial thrombosis or venous thrombosis,if control is good,registration is possible. 2.Patient who meets definition of NYHA 2 or has history of myocardial infarction,unstable angina or congestive heart failure 3.Patient with sever arrhythmia who needed medication,excluded atrial fibrillation or paroxysmal supraventricular tachycardia 4.Patient with uncontrolled hypertension(BPs>=150mmHg or BPd>=100mmHg irrespective of treatment) 5.Unhealed wound,ulcer and fracture 6.Patient with positive HBs antigen,HBc antibody or HBs antibody and HPV-DNA>=2.1 log copies/ml 7.HIV infection 13)Patient who received other test drug within 30 days prior to this treatment 14)Attending physician decides to entry inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified