Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer

May 7, 2014 updated by: Sang-Young Ryu, Korea Cancer Center Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 139-706
        • Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IP Chemotherapy
Patients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles
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
Other Names:
  • Carboplatin
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 year progression-free survival rate.
Time Frame: 2 Year after initial surgery

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median overall survival
Time Frame: From entry into the study to 5 year after treatment or until half of participants are dead
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
5 year progression-free survival rate
Time Frame: 5 year after initial surgery
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
5 year overall survival rate
Time Frame: 5 year after initial surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Cancer Center Hospital

Investigators

  • Principal Investigator: SANG YOUNG RYU, M.D., Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 7, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCCH GY 3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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