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Weekly liposomal doxorubicin and cisplatin chemotherapy for patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, phase I study

Weekly liposomal doxorubicin and cisplatin chemotherapy for patients with ovarian cancer, phase I study

3

(case1) 68 y.o. recurrent ovarian cancer, serous carcinoma, history of carboplatin hypersensitive reaction, performance status 0 (case2) 56 y.o. recurrent peritoneal cancer, serous carcinoma, history of carboplatin hypersensitive reaction, performance status 0 (case3) 81 y.o. ovarian cancer, serous carcinoma, history of carboplatin hypersensitive reaction, performance status 0

Number of enrollments: 3 patients 13 May 2020- 6 August 2020

Cases severe adverse events during the present trial was lasted as bellow. #1 peripheral neuropathy (Grade3, not related) #2 constipation (Grade3, related)

Primary endpoint Although 3 patients were enrolled at level 0, this study was discontinued due to prolonged thrombocytopenia in 2 patients, and the MTD was not obtained. Secondary endpoint Efficacy The planned treatment was completed in one of the enrolled patients, and she had no signs of recurrence on March 18, 2022 (PFS, 20 months) Safety #1 peripheral neuropathy (Grade3, one patient) #2 constipation (Grade3, one patient)

Although 3 patients were enrolled at level 0, this study was discontinued due to prolonged thrombocytopenia in 2 patients, and the MTD was not obtained. On efficacy of secondary endpoint, we had one patient with no recurrent disease during 20 months. On safety, we had no severe adverse effect including cisplatin hypersensitive reaction.

Oct. 01, 2022

No

We did not plan IPD in the present trial.

https://jrct.niph.go.jp/latest-detail/jRCTs031200007

Tate Shinichi

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba City, Chiba

state@faculty.chiba-u.jp

Tate Shinichi

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba City, Chiba

+81-43-222-7171

state@faculty.chiba-u.jp

Complete

April. 10, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Ptients with histologically proven ovarian cancer who has received paclitaxel and carboplatin combination therapy in thier previous therapy.
(2) Ptients who could not receive paclitaxel and carboplatin combination therapy because of their adverse effects (carboplatin hypersensitivity reaction <= grade 2 or paclitaxel neurotoxicity>= grade3 )..
(3) Age 20-79 year
(4) Patient has a duration of 2 weeks or more from the end of the previous treatment.
(5) Patient had Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 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 slight change in normal range
(7) Patients gave informed written consent.
(8) Patients without hypersensivity reaction of liposomal doxorubicin and cisplatin

(1) New York Heart Association (NYHA) Class II or greater congestive heart failure, or serious arrhythmias requiring medication for treatment.
(2) Known history of hypersensitivity to paclitaxeal and carboplatin (grade >=3)
(3) Known history of myocardial infarction within 6 months prior to the enrollment.
(4) Patients with liver cirrhosis or interstitial pneumonia
(5) Patients with gastrointestinal fresh bleeding required with blood transfusion repeatedly
(6) Patients with psychic disturbance required with the treatment or in the treatment with an antipsychotic drug
(7) Patients with uncontrolled diabetes
(8) History of bowel obstruction, including sub-occlusive disease
(9) Multiple primary cancers.
(10) Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician.

Female

ovarian cancer

The starting dose of level 0 (PLD 7.5 mg/m2, CDDP 15 mg/m2), was chosen from 1/4 dose of PLD 30 mg/m2, CALYPSO study and 1/3 dose of CDDP 45 mg/m2/3weeks). At least three patients were treated at each dose level. Dose escalation to PLD; 10 (level 1), 12,5 (level 2), 15 mg/m2 (level 3), CDDP 20 (level 2), 25 mg/m2 (level 3, 4) was performed in accordance with a modified Fibonacci scale. Three additional patients were entered at the same dose level if DLT was observed in one of the first three patients. The MTD was defined as the dose level at which two patients out of three to six patients experienced DLT. DLT was defined as (a) >= grade 3 non-hematologic toxicity, (b) grade 4 thrombocytopenia, (c) grade 4 grannulocytopenia lasting for more than seven days, or (d) Febrile neutropenia. We evaluate the safety in two cycle in each patients at each level.The final determination of MTD or further dose escalation was made by a monitoring committee consisting of three independent members.

ovarian cancer

phase 1 study

D000077216

D060828

Frequency of dose limiting toxicity at each level

Progresssion-free survival
Effect of chemotherapy
Overall survival
Other adverse effects

+81-43-226-2616

none