Status:
COMPLETED
Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
Lead Sponsor:
Gynecologic Oncology Trial & Investigation Consortium
Collaborating Sponsors:
Japanese Gynecologic Oncology Group
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
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) injec...
Detailed Description
This is a randomized, multicenter international study. Patient are stratified according to Residual tumor diameter(\[0cm(No residual)\] vs. \[0cm\<residual\<1cm\] vs. \[1cm\<residual\<2cm\] vs. \[\>2 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
655 Patients enrolled
Trial Details
Trial ID
NCT01506856
Start Date
May 1 2010
End Date
February 28 2021
Last Update
September 15 2023
Active Locations (62)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, Pa 15213
2
Queen Mary Hospital
Hong Kong, High West, Hong Kong, 102
3
Aichi Cancer Center Hospital
Chikusa, Aichi-ken, Japan, 464-0021
4
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, Japan, 036-8203