Clinical trial NCT00919984: Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer
Official title: Phase II Clinical Trial of Intravenous Paclitaxel and Carboplatin Plus Intraperitoneal Paclitaxel as an Adjuvant Chemotherapy in Patients With Optimally Debulked Advanced Epithelial Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Keywords: OVARIAN NEOPLASMS
ADJUVANT CHEMOTHERAPY
INTRAPERITONEAL CHEMOTHERAPY
Lead sponsor: Korea Cancer Center Hospital
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 22
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: 2 year progression-free survival rate.
timeFrame: 2 Year after initial surgery
Secondary outcomes:
measure: Median overall survival
timeFrame: From entry into the study to 5 year after treatment or until half of participants are dead
measure: 5 year progression-free survival rate
timeFrame: 5 year after initial surgery
measure: 5 year overall survival rate
timeFrame: 5 year after initial surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Study officials:
affiliation: KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES
name: SANG YOUNG RYU, M.D.
role: PRINCIPAL_INVESTIGATOR
References: