Phase II Trial of Weekly Intravenous Paclitaxel plus Three Weekly Intraperitoneal Carboplatin Administration for Suboptimally Debulked Ovarian and Primary Peritoneal Carcinoma Incorporating Pharmacogenomic Analysis.
- Conditions
- Ovarian Cancer, Peritoneal Cancer
- Registration Number
- JPRN-UMIN000001713
- Lead Sponsor
- Development Organization for Frontier Medical Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 80
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate (RECIST)
- Secondary Outcome Measures
Name Time Method 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.