A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

April 3, 2012 updated by: Taek Sang Lee, Korean Gynecologic Oncology Group

A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

purpose Primary endpoint

  • To evaluate the 24 month disease free survival Second endpoints
  • To evaluate the 24 month overall survival To analyze the toxicity and the quality of life

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Approximately 48 month from the date of IRB approval

Patients enrolled in this study targets approximately 314 people. Completion of patient enrollment is expected to take approximately 24 month, approximately 24 month follow-up period is expected to be needed

Study Type

Interventional

Enrollment (Anticipated)

314

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
        • Korea Institute of Radiological and 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.
  • Pathologically Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS) have been diagnosed with possible participation.
  • Patients with CA-125 (biochemical recurrence), as described below elevation or clinically measurable lesions or the measurement is not possible, as there should be evidence of recurrence.
  • If at least one (record as the longest diameter) can be accurately measured in at least one lesion that is defined. For each lesion, such as MRI or CT, when measured by traditional methods should be at least 20mm spiral CT (spiral CT) have been measured to be less than 10mm when.
  • Neutrophil (ANC) by 1500 / ㎣ more Platelet count 100,000 / ㎣ more Serum creatinine concentration 1.5mg/dL (133mol / l) or creatinine clearance less than 60ml/min should be at least two.

Exclusion Criteria:

  • Patients must be at least 18 years of age.
  • Patients with epithelial ovarian, fallopian tube cancer bokmakam or pathological diagnosis of recurrent states there must be must be present.

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: drug effect

Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.

Subjects assigned to Arm II Gemcitabine and Latin Neople every week based on the first day of the outpatient / inpatient treatment receive it. The subjects first received Gemcitabine given over 30 minutes followed by 30 minutes will be administered Neople Latin week.

Gemcitabine and eighth day of the foreign / hospitalization are given over 30 minutes.

Regimen of the progression of the disease, the subject can not continue to deny or toxic dose every 3 weeks until at least 6 cycles should be administered to. Subjects completed six cycles of medication which responds subjects, the researchers believe it is necessary to sustain if the regimen is
Drug: carboplatin and paclitaxel
Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.
Other Names:
  • carboplatin , paclitaxel and Gemcitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24month progression free survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity Profile
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

Korean Gynecologic Oncology Group

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

March 1, 2010

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG3017

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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