Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01669226
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : December 19, 2016
Fudan University
Shanghai Jiao Tong University School of Medicine
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group

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.

Condition or disease Intervention/treatment Phase
Bulky Stage IIIC and IV Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Drug: PEip (weekly) and TCiv Drug: TCiv Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : July 2016

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:
  • platinum
  • VP 16
  • 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:
  • taxane
  • platinum

Primary Outcome Measures :
  1. 12-month disease non-progression rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to 120 months ]
  2. Completion rate of intraperitoneal chemotherapy. [ Time Frame: up to 6 months ]
  3. 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. ]
  4. Overall Survival [ Time Frame: up to 120 months ]
  5. adverse effects [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01669226

Layout table for location information
China, Jiangsu
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Wuxi Cancer Hospital
Wuxi, Jiangsu, China
China, Shanghai
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China, 200030
Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai, China
Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University
Shanghai, Shanghai, China
Fudan University Cancer Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Gynecologic Oncology Group
Fudan University
Shanghai Jiao Tong University School of Medicine
Shanghai Zhongshan Hospital
Layout table for investigator information
Principal Investigator: Rongyu Zang, MD,PhD Shanghai Gynecologic Oncology Group

Additional Information:
Layout table for additonal information
Responsible Party: Shanghai Gynecologic Oncology Group Identifier: NCT01669226     History of Changes
Other Study ID Numbers: V01-2009-03
SGOG OV1 ( Other Identifier: SGOG )
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by Shanghai Gynecologic Oncology Group:
Ovarian Cancer
intraperitoneal chemotherapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Albumin-Bound Paclitaxel
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators