Trial | NCT01669226  Report issue

Title

First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    215
The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.
Study Started
Apr 30
2009
Primary Completion
Sep 30
2015
Study Completion
Jul 31
2016
Last Update
Dec 19
2016
Estimate

Drug PEip (weekly) and TCiv

IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5

  • Other names: platinum, VP 16, taxane

Drug TCiv

IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5

  • Other names: taxane, platinum

Regimen A: Standard TCiv therapy Active Comparator

IV paclitaxel plus carboplatin or docetaxel plus carboplatin

Regimen B, PEip and TCiv therapy Experimental

Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin

Criteria 

Inclusion Criteria:

Age ≥18 years to ≤ 75 years.
Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone
Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm
Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection.
ECOG performance 0-2.
No more than 3 cycles of chemotherapy prior to surgery.
Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin < 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min.
Comply with intraperitoneal chemotherapy and follow-up.
Written informed consent.

Exclusion Criteria:

Low-malignant potential ovarian tumor.
Laboratory testing insufficiency. Hemoglobin < 10 g/dL. Renal insufficiency with serum creatinine > 1.6.
Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3.
Active infection.
Clinically significant gastrointestinal abnormalities.
Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure.
Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Prior invasive malignancies within the last 5 years showing activity of disease.
No Results Posted