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

This study has been completed.
Sponsor:
Collaborators:
Fudan University
Shanghai Jiao Tong University School of Medicine
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01669226
First received: August 8, 2012
Last updated: July 23, 2016
Last verified: October 2015
  Purpose
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 Intervention Phase
Bulky Stage IIIC and IV Epithelial Ovarian Cancer,
Fallopian Tube Cancer,
Primary Peritoneal Carcinoma
Drug: PEip (weekly) and TCiv
Drug: TCiv
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Shanghai Gynecologic Oncology Group:

Primary Outcome Measures:
  • 12-month disease non-progression rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: up to 120 months ] [ Designated as safety issue: No ]
  • Completion rate of intraperitoneal chemotherapy. [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: up to 120 months ] [ Designated as safety issue: No ]
  • adverse effects [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 230
Study Start Date: April 2009
Study Completion Date: July 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669226

Locations
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
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
Investigators
Principal Investigator: Rongyu Zang, MD,PhD Shanghai Gynecologic Oncology Group
  More Information

Additional Information:
Responsible Party: Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01669226     History of Changes
Other Study ID Numbers: V01-2009-03 
Study First Received: August 8, 2012
Last Updated: July 23, 2016
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Neoplasms by Histologic Type
Paclitaxel
Etoposide
Docetaxel
Etoposide phosphate
Taxane
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016