Bevacizumab combined chemotherapy with gemcitabine and irinotecan in patients with platinum-refractory/resistant ovarian cancer: a phase II trial

JRCT ID: jRCTs031220424

Registered date:28/10/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: ovarian cancer
• Date of first enrollment: 28/10/2022
• Target sample size: 51
• Study type: Interventional
• Intervention(s): Irinotecan (50 mg/m2) is administrated intravenously over 90 minutes on Days 1 and 8, followed by gemcitabine at the tailored dose over 30 minutes. The doses of irinotecan and gemcitabine increase or decrease according to the hematological or non-hematological toxicity. Bevacizumab is administrated at 15 mg/kg every 3 weeks. This study is continued as long as possible until PD is confirmed.

Outcome(s)

• Primary Outcome: Progression free survival

Secondary Outcome

Efficacy of bevacisumab combined chemotherapy with gemcitabine and irinotecan
Overall survival
Adverse effect

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients with histologically proven ovarian cancer who has the resistant or refractory for paclitaxel and carboplatin combination therapy in thier previous therapy
(2) Patients had recieved less than four previous chemotherapy.
(3) Age more than twenty years old
(4) Patient has a duration of 3 weeks or more from the end of the previous treatment. (Patients has a duration of 4 weeks or more if previous regimen was triweekly CBDCA/PTX.)
(5) Patient had Eastern Cooperative Oncolog y Group (ECOG) performance status 0 or 1 and had be expected to alive more than three months.
(6) Adequate bone marrow function ( WBCs >=2,000/mm3, Neutrophil >=1,500/mm3, platelets >= 100,000/mm3), hepatic function (AST(GOT)=<90 U/I, ALT(GPT) 63 U/l =< 63 U/l ) and renal function ( serum creatinine =< 1.0 mg /dl, urea nitrogen =< 25 mg /dl), total bilirubin =< 1.0 mg /dl , Electrocardiogram; normal or slig ht change in normal range
(7) Patients gave informed written consent.
(8) Patients without hypersensivity reaction of bev acizumab, gemcitabine and irinotecan.

Exclude criteria

1. Patients had contraindications to bevacizumab (Patients who received surgery within 28 days, who had active pulmonary hemorrhage, cerebral hemorrhage, congenital bleeding diathesis, coagulopathy, history of cerebral infarction, active deep vein thrombosis, pulmonary embolism, uncontrolled hypertension (grade 3 or higher), proteinuria (Grade >= 3, UPC >= 3.5))
2.Patients with homozygous for UGT1A1*6 or UGT1A1*28 and Patients with heterozygous for UGT1A1*6 and UGT1A1*28
3. New York Heart Association (NYHA) Class II or greater congestive heart failure, or serious arrhythmias requiring medication for treatment. (We are able to enroll patients with hypertension-associated left ventricular hypertrophy, mild left ventricular overload, and mild right bundle branch block.)
4. Known history of hypersensitivity to bevacizumab, gemcitabine and irinotecan
5. Known history of myocardial infarction within 6 months prior to the enrollment.
6. Patients with liver cirrhosis or interstitial pneumonia
7. Patients with g astrointestinal fresh bleeding required with blood transfusion repeatedly
8. Patients with psychic disturbance required with the treatment or in the treatment with an antipsychotic drug
9. Patients with uncontrolled diabetes
10. History of bowel obstruction, including sub-occlusive disease
11. Multiple primary cancers.
12. Patients who are inappropriate to enter this study with any safety reasons,judg ed by the treating physician.

Related Information

• Primary Sponsor: Koga Kaori
• Source(s) of Monetary Support: Clinical Research Initiation Fund (of Chiba University Hospital)