Ovarian Cancer, Peritoneal Cancer
Conditions
Interventions
Weekly Paclitaxel 80 mg/m2/week plus 3 Weekly Carboplatin AUC6
Sponsors
Development Organization for Frontier Medical Therapeutics
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed epithelial ovarian or primary peritoneal cancer 2) FIGO Stage II, III, and IV 3) Bard IP Port is placed as Implantable Port System 4) Chemotherapy or radiation therapy should not have been given for the current disease. 5) Protocol treatment must be started within 6 weeks after surgery. 6) The patient must have measurable disease (RECIST) after initial debulking surgery. 7) Age 20 years or older 8) ECOG Performance Status 0-2 9) Life expectancy must be 3 months or longer 10) Patient must have appropriate organ function (bone marrow, cardiac, pulmonary, liver, kidney) and the laboratory value within 7 days before the protocol treatment must be ANC 2,000/mm3 or more Platelet 100,000/mm3 or more GOT, GPT x2 institutional ULN or less (not applicable for patients with liver metastasis) Serum Total Bilirubin 1.5 mg/dL or less Serum Creatinine 1.5 mg/dL or less Preoperative EKG Normal 11) Written informed consent must be obtained for the study including blood or tissue sampling
Exclusion criteria
Exclusion criteria: 1) Patients who did not meet the above mentioned inclusion criteria. 2) Patients who underwent colo-rectal resection at the initial debulking surgery 3) Patients with active double cancer excluding skin cancer except for melanoma 4) Patients with past history of cancer, and who meet following criteria is NOT eligible Patients who received radiotherapy to the abdomen or pelvis Patients who received chemotherapy for abdominal or pelvic cancer Patients who received chemotherapy for breast cancer within 3 years since last chemotherapy Patients who have the history of malignancy other than mentioned above within 5years 5) Patients with serious complications Examples: Severe cardiac disease, celebro-vascular disorder, uncontrollable diabetes and/or hypertension, severe infections, pulmonary fibrosis, interstitial pneumonia, bleeding or active peptic ulcer, or double cancer, or severe neurological disease. 6) Patients with severe hypersensitivities 7) Patients with history of hypersensitivity reactions to polyoxyethylated castor oil 8) Patients with obvious infectious disease 9) Patients with peripheral (sensory or motor) neuropathy Grade 2or greater 10) Patients with clinical psycho-neurological disease 11) Patients who are pregnant or breast feeding or possibility of pregnancy 12) Patients with receiving experimental medicine at the time of entry 13) Patients whom investigators determined it impossible to complete the protocol treatment safely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate (RECIST) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response duration, Complete response duration, Stable duration, Progression-free survival, Overall survival, Toxicity profiles, frequency, grade, timing, Feasibility of genomic predictive factors for response, Feasiblity of genomic predictive factors for progression-free survival, Establishment of new predictive markers, Pharmacokinetics of serum paclitaxel. | — |
Countries
Japan
Contacts
Public ContactKeiichi Fujiwara
Saitama Medical University International Medical Center Gynecologic Oncology
Outcome results
None listed