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

Primary Purpose

Bulky Stage IIIC and IV Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PEip (weekly) and TCiv
TCiv
Sponsored by
Shanghai Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulky Stage IIIC and IV Epithelial Ovarian Cancer focused on measuring Ovarian Cancer, intraperitoneal chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongda Hospital Southeast University
  • Suzhou Municipal Hospital
  • Wuxi Cancer Hospital
  • Shanghai Zhongshan Hospital
  • Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
  • Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University
  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regimen B, PEip and TCiv therapy

Regimen A: Standard TCiv therapy

Arm Description

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

IV paclitaxel plus carboplatin or docetaxel plus carboplatin

Outcomes

Primary Outcome Measures

12-month disease non-progression rate

Secondary Outcome Measures

Progression-free survival
Completion rate of intraperitoneal chemotherapy.
Quality of life assessments
Overall Survival
adverse effects

Full Information

First Posted
August 8, 2012
Last Updated
December 15, 2016
Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01669226
Brief Title
First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
Acronym
AICE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulky Stage IIIC and IV Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords
Ovarian Cancer, intraperitoneal chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen B, PEip and TCiv therapy
Arm Type
Experimental
Arm Description
Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
Arm Title
Regimen A: Standard TCiv therapy
Arm Type
Active Comparator
Arm Description
IV paclitaxel plus carboplatin or docetaxel plus carboplatin
Intervention Type
Drug
Intervention Name(s)
PEip (weekly) and TCiv
Other Intervention Name(s)
platinum, VP 16, taxane
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TCiv
Other Intervention Name(s)
taxane, platinum
Intervention Description
IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Primary Outcome Measure Information:
Title
12-month disease non-progression rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
up to 120 months
Title
Completion rate of intraperitoneal chemotherapy.
Time Frame
up to 6 months
Title
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.
Title
Overall Survival
Time Frame
up to 120 months
Title
adverse effects
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongyu Zang, MD,PhD
Organizational Affiliation
Shanghai Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Wuxi Cancer Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Fudan University Cancer Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31383985
Citation
Shi T, Jiang R, Pu H, Yang H, Tu D, Dai Z, Cai Y, Zhang Y, Cheng X, Jia H, Tu R, Wang H, Tang J, Luan Y, Cai S, Zang R; SGOG-OV/AICE Investigators. Survival benefits of dose-dense early postoperative intraperitoneal chemotherapy in front-line therapy for advanced ovarian cancer: a randomised controlled study. Br J Cancer. 2019 Aug;121(5):425-428. doi: 10.1038/s41416-019-0543-1. Epub 2019 Aug 6.
Results Reference
derived
Links:
URL
http://www.ShanghaiGOG.org
Description
Shanghai Gynecologic Oncology Group

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First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer

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