Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer

Ovarian Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00919984
• Other study ID #: KCCH GY 3001
• Status: Terminated
• Phase: Phase 2
• First received: June 7, 2009
• Last updated: May 7, 2014
• Start date: May 2007
• Est. completion date: October 2010

Study information

• Verified date: May 2014
• Source: Korea Cancer Center Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Cancer Center Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 Year after initial surgery	No
Secondary	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	From entry into the study to 5 year after treatment or until half of participants are dead	No
Secondary	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	5 year after initial surgery	No
Secondary	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.	5 year after initial surgery	No