ovarian cancer ovarian cancer
Conditions
Interventions
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
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 sa
phase 1 study
Sponsors
Tate Shinichi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (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 = 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
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of dose limiting toxicity at each level | — |
Secondary
| Measure | Time frame |
|---|---|
| Progresssion-free survival Effect of chemotherapy Overall survival Other adverse effects | — |
Contacts
Public ContactShinichi Tate
Chiba University Hospital
Outcome results
None listed