Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer

NCT ID: NCT00919984

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-10-31

Brief Summary

Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer.

Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy.

Recently, intraperitoneal combination chemotherapy has been reported to be effective in ovarian cancer.

We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel + carboplatin plus intraperitoneal paclitaxel chemotherapy.

Detailed Description

Epithelial ovarian cancer is the leading cause of death from gynecologic malignancies worldwide. The recommended treatment includes primary surgery for diagnosis, staging, and cytoreduction, followed by chemotherapy. Epithelial ovarian cancer is more sensitive to cytotoxic drugs than other solid tumors, most patients with advanced ovarian cancer are recommended treatment with postoperative adjuvant chemotherapy. The recommended initial chemotherapy is generally platinum and taxane combination given by intravenous infusion every 3 weeks for 6 courses. This treatment resulted in complete remission in about 50% of ovarian cancer patients and pathologic complete response in 25~30% of patients.

However most patients with advanced ovarian cancer suffered recurrences after primary treatment, median progression free survival is 15.5-22months, and median overall survival is about 31-44months.

As residual ovarian cancer after surgery and initial recurrences are primarily confined to the abdomen, intraperitoneal administration of chemotherapy was proposed several decades ago. In 2006, Armstrong, et al., reported improvement of overall survival in ovarian cancer patient with optimal surgical debulking followed intraperitoneal paclitaxel + cisplatin chemotherapy. The National Cancer Institute (NCI) of the United States recommended to consider intraperitoneal chemotherapy in optimally debulking patients.

In Korea, however, there are few studies about postoperative adjuvant intraperitoneal chemotherapy in optimally debulked (residual mass <1cm) advanced ovarian cancer patients.

Therefore the investigators tend to evaluate the efficacy and feasibility of postoperative adjuvant intraperitoneal chemotherapy. (standard intravenous paclitaxel+carboplatin plus intraperitoneal paclitaxel chemotherapy)

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IP Chemotherapy

Patients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles

Group Type: EXPERIMENTAL

IP chemotherapy

Intervention Type: DRUG

IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles

Interventions

IP chemotherapy

IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles

Intervention Type: DRUG

Other Intervention Names

Paclitaxel; Carboplatin

Eligibility Criteria

Inclusion Criteria

1. Age >=20 and <=75

2. Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, tubal cancer

3. Stage 3 or 4

4. WBC >= 3500/mm3, ANC >= 1500/mm3, platelet >= 100000/mm3, hemoglobin >= 10 g/dl

5. Serum creatinine <= upper normal limit * 1.25

6. Total bilirubin <= 1.5mg/mm3, ALT/AST <= upper normal limit * 3, ALP <= upper normal limit * 3

7. Adequate compliance and geographical closeness which make adequate follow-up possible

8. GOG performance status 0-2

9. Anticipated survival >= 3 months

10. Who agreed to participate in this study and signed on informed consent form

Exclusion Criteria

1. History of chemotherapy or radiotherapy on abdomen/pelvis area

2. Pleural/pericardial effusion, ascites causing respiratory difficulties >= NCI-CTCAE grade 2

3. History of other cancers within 5 years

4. History of unapproved therapy within 30 days before enrollment

5. Other serious diseases which could threat the safety of participants or impair the ability of participants to complete the participation.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Korea Cancer Center Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang-Young Ryu

Chair of Cerivcal/Ovarian Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SANG YOUNG RYU, M.D.

Role: PRINCIPAL_INVESTIGATOR

KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES

Locations

Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KCCH GY 3001

Identifier Type: -

Identifier Source: org_study_id