First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer (AICE)

December 15, 2016 updated by: Shanghai Gynecologic Oncology Group

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Southeast University
      • Suzhou, Jiangsu, China
        • Suzhou Municipal Hospital
      • Wuxi, Jiangsu, China
        • Wuxi Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Zhongshan Hospital
      • Shanghai, Shanghai, China
        • Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
      • Shanghai, Shanghai, China
        • Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regimen B, PEip and TCiv therapy
Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
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:
  • VP 16
  • platinum
  • taxane
Active Comparator: Regimen A: Standard TCiv therapy
IV paclitaxel plus carboplatin or docetaxel plus carboplatin
Drug: TCiv
IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Other Names:
  • platinum
  • taxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12-month disease non-progression rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: up to 120 months
up to 120 months
Completion rate of intraperitoneal chemotherapy.
Time Frame: up to 6 months
up to 6 months
Quality of life assessments
Time Frame: baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.
baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.
Overall Survival
Time Frame: up to 120 months
up to 120 months
adverse effects
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Fudan University
Shanghai Zhongshan Hospital
Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Rongyu Zang, MD,PhD, Shanghai Gynecologic Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V01-2009-03
  • SGOG OV1 (Other Identifier: SGOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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