First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer

Fallopian Tube Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669226
• Other study ID #: V01-2009-03
• Secondary ID: SGOG OV1
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2012
• Last updated: December 15, 2016
• Start date: April 2009
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Shanghai Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: July 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Fudan University Cancer Hospital	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	Shanghai	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai
China	Suzhou Municipal Hospital	Suzhou	Jiangsu
China	Wuxi Cancer Hospital	Wuxi	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Gynecologic Oncology Group	Fudan University, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month disease non-progression rate		12 months	No
Secondary	Progression-free survival		up to 120 months	No
Secondary	Completion rate of intraperitoneal chemotherapy.		up to 6 months	Yes
Secondary	Quality of life assessments		baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.	No
Secondary	Overall Survival		up to 120 months	No
Secondary	adverse effects		Participants will be followed for the duration of hospital stay, an expected average of 5 weeks	Yes

External Links

•   Shanghai Gynecologic Oncology Group