Brief Title
A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Official Title
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
Brief Summary
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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
24month progression free survival
Secondary Outcome
Toxicity Profile
Condition
Fallopian Tube Cancer
Intervention
carboplatin and paclitaxel
Study Arms / Comparison Groups
drug effect
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
314
Start Date
March 2010
Completion Date
March 2014
Primary Completion Date
March 2014
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01570582
Organization ID
KGOG3017
Responsible Party
Principal Investigator
Study Sponsor
Korean Gynecologic Oncology Group
Study Sponsor
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Verification Date
April 2012