First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer (AICE)
This study is currently recruiting participants.
Verified January 2013 by Shanghai Gynecologic Oncology Group
Sponsor:
Shanghai Gynecologic Oncology Group
Collaborators:
Fudan University
Shanghai JiaoTong University School of Medicine
Soochow University (Jiangsu)
Tongji University (Shanghai)
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01669226
First received: August 8, 2012
Last updated: January 2, 2013
Last verified: January 2013
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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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 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:
|
|
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:
|
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669226
Contacts
| Contact: Jie Tang, MD,PhD | +862164175590 | fudanGOG@gmail.com |
| Contact: Yuting Luan, RN | +862164175590 | yutingluan@163.com |
Locations
| China, Jiangsu | |
| Suzhou Municipal Hospital | Recruiting |
| Suzhou, Jiangsu, China | |
| Contact: Mi Zhang, MD +8613584887057 z_m_7_0@yahoo.com.cn | |
| Wuxi Cancer Hospital | Recruiting |
| Wuxi, Jiangsu, China | |
| Contact: Shan Su, MD +8613861768827 ssli2004@163.com | |
| China, Shanghai | |
| Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University | Not yet recruiting |
| Shanghai, Shanghai, China | |
| Contact: Xipeng Wang, MD,PhD xipengwang@hotmail.com | |
| Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine | Not yet recruiting |
| Shanghai, Shanghai, China | |
| Contact: Lihua Qiu, MD,PhD +862158752345 lilyqiulh@126.com | |
| China | |
| Fudan University Cancer Hospital | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Yuting Luan, RN +862164175590 yutingluan@163.com | |
| Principal Investigator: Rongyu Zang, MD,PhD | |
Sponsors and Collaborators
Shanghai Gynecologic Oncology Group
Fudan University
Shanghai JiaoTong University School of Medicine
Soochow University (Jiangsu)
Tongji University (Shanghai)
Investigators
| Principal Investigator: | Rongyu Zang, MD,PhD | Shanghai Gynecologic Oncology Group |
More Information
No publications provided
| 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: | January 2, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Shanghai Gynecologic Oncology Group:
|
Ovarian Cancer intraperitoneal chemotherapy |
Additional relevant MeSH terms:
|
Carcinoma Ovarian Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases Etoposide phosphate Cisplatin Etoposide Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013