Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer

This study has been terminated.
(This study stopped due to slow accrual.)
Sponsor:
Information provided by (Responsible Party):
Sang-Young Ryu, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier:
NCT00919984
First received: June 7, 2009
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: IV Paclitaxel+Carboplatin plus IP Paclitaxel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Korea Cancer Center Hospital:

Primary Outcome Measures:
  • 2 year progression-free survival rate. [ Time Frame: 2 Year after initial surgery ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Median overall survival [ Time Frame: From entry into the study to 5 year after treatment or until half of participants are dead ] [ Designated as safety issue: No ]
    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

  • 5 year progression-free survival rate [ Time Frame: 5 year after initial surgery ] [ Designated as safety issue: No ]
    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 overall survival rate [ Time Frame: 5 year after initial surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: May 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: IV Paclitaxel+Carboplatin plus IP Paclitaxel
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:
  • Paclitaxel
  • Carboplatin

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919984

Locations
Korea, Republic of
Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Seoul, Korea, Republic of, 139-706
Sponsors and Collaborators
Korea Cancer Center Hospital
Investigators
Principal Investigator: SANG YOUNG RYU, M.D. KOREA CANCER CENTER HOSPITAL, KOREA INSTITUTE OF RADIOLOGICAL & MEDICAL SCIENCES
  More Information

No publications provided

Responsible Party: Sang-Young Ryu, Chair of Cerivcal/Ovarian Cancer Center, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT00919984     History of Changes
Other Study ID Numbers: KCCH GY 3001
Study First Received: June 7, 2009
Last Updated: March 27, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Cancer Center Hospital:
OVARIAN NEOPLASMS
ADJUVANT CHEMOTHERAPY
INTRAPERITONEAL CHEMOTHERAPY

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 22, 2014