Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial (iPocc)
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Epithelial ovarian cancer, Fallopian tube cancer, peritoneal cancer, intraperitoneal therapy, Carboplatin, Paclitaxel
Eligibility Criteria
Inclusion Criteria:
- Patients assumed to have a stageII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
Patients scheduled to undergo laparotomy
*Both optimal and suboptimal patients will be eligible for the study (Suboptimal patients, as well as those who undergo only exploratory laparotomy, are eligible.)
- ECOG Performance Status: 0-2
- Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy)
- Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery
Lab data and clinical examination: Data within 28 days before the scheduled date of surgery
- Neutrophil count ≧ 1,500 /mm3
- Platelet count ≧ 100,000 /mm3
- AST (GOT) ≦ 100 IU/L
- ALT (GPT) ≦ 100 IU/L
- Total bilirubin < 1.5 mg/dL
- Serum Creatinine < 1.5 mg/dL
- Electrocardiogram (ECG): Patients with normal ECG, Asymptomatic patients with abnormal ECGs not requiring medical intervention
- Neuropathy(Both motor and sensory) ≦ Grade1 (CTCAE Version 4.0)
- Patients expected to survive longer than 3 months from the start date of the protocol treatment
- Patients aged 20 years and older at the time of tentative registration (with no upper age limit)
- Patients who provide written informed consent for participation in this trial
Exclusion Criteria:
- Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
- Patients who have received previous chemotherapy or radiation therapy to treat the current disease
- 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)
- 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
- Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
- Patients with a pleural effusion requiring continuous drainage
- Patients with an active infection requiring antibiotics
- Patients who are pregnant, nursing or of child-bearing potential
- Patients with evidence upon physical examination of brain tumor and any brain metastases
- Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason
- Patients with any signs/symptoms of interstitial pneumonia
Sites / Locations
- University of Pittsburgh
- Queen Mary Hospital
- Aichi Cancer Center Hospital
- Hirosaki University School of Medicine & Hospital
- The Jikei University School of Medicine, Kashiwa Hospital
- NHO Shikoku Cancer Center
- Ehime University Hospital
- University of Fukui Hospital
- Gunma University Hospital
- Gunma Prefectural Cancer Center
- NHO Kure Medical Center And Chugoku Cancer Center
- Miyoshi Central Hospital
- Hyogo Cancer Center
- Japanese Red Cross Society Himeji Hospital
- Kobe City Medical Center General Hospital
- Hyogo Medical College Hospital
- Tsukuba University Hospital
- Iwate Medical University Hospital
- Tokai University Hospital
- Nippon Medical University Musasi Kosugi Hospital
- Yokohama Municipal Citizen's Hospital
- Mie University Hospital
- Mie Prefectural General Medical Center
- Tohoku University Hospital
- Shinshu University Hospital
- Nara Medical University Hospital
- Okinawa Prefectural Chubu Hospital
- Kaizuka City Hospital
- Osaka University Hospital
- Osaka Medical College Hospital
- Saitama Medical University International Medical Center
- Saitama Medical University Saitama Medical Center
- Shizuoka Cancer Center
- Jichi Medical University Hospital
- Tochigi Cancer Center
- Juntendo University Hospital
- The University of Tokyo Hospital
- The Jikei University Daisan Hospital
- The Cancer Institute Hospital Of JFCR
- The Jikei University Hospital
- Showa University Hospital
- Keio University Hospital
- Tokyo Women's Medical University Medical Center East
- Tottori University
- Yamaguchi University Hospital
- NHO Kyusyu Medical center
- JA Hiroshima General Hospital
- Kagoshima City Hospital
- University Hospital, Kyoto Prefectural University of Medicine
- Saiseikai Nagasaki Hospital
- Niigata Cancer Center Hospital
- Niigata University Medical & Dental Hospital
- Osaka Medical Center for Cancer and Cardiovascular Diseases
- Tottori Municipal Hospital
- Korea Cancer Center Hospital
- Gangnam Severance Hospital in Korea
- Asan Medical Center
- Ewha Womans University Medical Center
- Shinchon Severance Hospital
- University of Otago - Christchurch/Christchurch Women's Hospital
- KK Women's and Children's Hospital
- National University Hospital of Singapore
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard treatment: dd-TCiv therapy
Study treatment: dd-TCip therapy
Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks