Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Conditions
Interventions
Tri-weekly Intravenous Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
Sponsors
Gynecologic Oncology Trial and Investigation Consortium / Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patient assumed to have a stage II-IV epithelial ovarian, Fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis 2) Patient scheduled to undergo laparotomy (*Both optimal and suboptimal patients will be eligible to the study) 3) ECOG Performance Status: 0-2 4) Patient consented to place the IP implantable port system, if assigned to IP treatment regimen 5) Patient expected to receive the first study treatment within 8 weeks after the comprehensive staging surgery 6) Reasonable organ function: Must be assessed within 28 days prior to Laparotomy 7) Patient expected to survive longer than 3 months from the starting date of the protocol therapy 8) Age: 18 or older 9) Patient must have signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer 2) Patients who have received previous chemotherapy or radiation therapy to treat the current disease 3) Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study) 4) Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder 5) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil 6) Patients with a pleural effusion requiring continuous drainage 7) Patients with an active infection requiring antibiotics 8) Patients who are pregnant, nursing or of child-bearing potential 9) Patients with evidence upon physical examination of brain tumor and any brain metastases 10) Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason 11) Patients with any signs/symptoms of interstitial pneumonia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PhaseII - Adverse event PhaseIII - Progression Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Suvival Tumor Response Adverse event Treatment completion rate Quality of Life Cost effective | — |
Countries
Japan,Asia(except Japan),North America
Contacts
Public ContactSyoji Nagao
Okayama University Hospital Department of Obstetrics and Gynecology
Outcome results
None listed