Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial

Completed · Phase 2/Phase 3

Conditions studied: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

In brief

The purpose of this study is: Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every 3 weeks (dd-TCip therapy). Phase B: To compare the efficacy and safety of the following two treatment regimens as first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary peritoneal cancer.

Key facts

Study ID

NCT01506856

Run by

Gynecologic Oncology Trial & Investigation Consortium

People needed

655

Starts

2010-05-01

Expected to finish

2021-02-28

Last updated by the study team

2023-09-15

Who can join

Age: 20 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Queen Mary Hospital — Hong Kong, High West, Hong Kong
• Aichi Cancer Center Hospital — Chikusa, Aichi-ken, Japan
• Hirosaki University School of Medicine & Hospital — Hirosaki-shi, Aomori, Japan
• The Jikei University School of Medicine, Kashiwa Hospital — Kashiwa, Chiba, Japan
• NHO Shikoku Cancer Center — Matsuyama, Ehime, Japan
• Ehime University Hospital — Toon-shi, Ehime, Japan
• University of Fukui Hospital — Yoshida, Fukui, Japan
• Gunma University Hospital — Maebashi, Gunma, Japan
• Gunma Prefectural Cancer Center — Ōta, Gunma, Japan
• NHO Kure Medical Center And Chugoku Cancer Center — Kure, Hiroshima, Japan
• Miyoshi Central Hospital — Miyoshi, Hiroshima, Japan
• Hyogo Cancer Center — Akashi, Hyōgo, Japan
• Japanese Red Cross Society Himeji Hospital — Himeji, Hyōgo, Japan
• Kobe City Medical Center General Hospital — Kobe, Hyōgo, Japan
• Hyogo Medical College Hospital — Nishinomiya, Hyōgo, Japan
• Tsukuba University Hospital — Tsukuba, Ibaraki, Japan
• Iwate Medical University Hospital — Morioka, Iwate, Japan
• Tokai University Hospital — Isehara, Kanagawa, Japan
• Nippon Medical University Musasi Kosugi Hospital — Kawasaki-shi, Kanagawa, Japan
• Yokohama Municipal Citizen's Hospital — Yokohama, Kanagawa, Japan
• Mie University Hospital — Tsu, Mie-ken, Japan
• Mie Prefectural General Medical Center — Yokkaichi, Mie-ken, Japan
• Tohoku University Hospital — Sendai, Miyagi, Japan
• Shinshu University Hospital — Matsumoto, Nagano, Japan
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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