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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


Phase 2
20 Years
75 Years
Not Enrolling
Female
Ovarian Neoplasms

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Trial Information

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


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)

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

2 year progression-free survival rate.

Outcome Description:

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.

Outcome Time Frame:

2 Year after initial surgery

Safety Issue:

No

Principal Investigator

SANG YOUNG RYU, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

South Korea: Institutional Review Board

Study ID:

KCCH GY 3001

NCT ID:

NCT00919984

Start Date:

May 2007

Completion Date:

October 2010

Related Keywords:

  • Ovarian Neoplasms
  • OVARIAN NEOPLASMS
  • ADJUVANT CHEMOTHERAPY
  • INTRAPERITONEAL CHEMOTHERAPY
  • Neoplasms
  • Ovarian Neoplasms

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