Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer

NCT00919984TerminatedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Korea Cancer Center Hospital

Enrollment

22

Start Date

2007-05-01

Completion Date

2010-10-01

Study Type

INTERVENTIONAL

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

Interventions

IP chemotherapy

Conditions

Ovarian Neoplasms

Eligibility

Age Range

20 Years – 75 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

2 year progression-free survival rate.

The time from randomization to the time of disease progression as determined by the investigator or death from any cause. Progression is diagnosed by imaging or serial tumor marker elevation.

Time frame: 2 Year after initial surgery

Secondary Outcomes

Median overall survival

Median observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol

Time frame: From entry into the study to 5 year after treatment or until half of participants are dead

5 year progression-free survival rate

The time from randomization to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause

Time frame: 5 year after initial surgery

5 year overall survival rate

Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol.

Time frame: 5 year after initial surgery

Locations

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