Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Cancer Center Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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.