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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

24month progression free survival

Outcome Time Frame:

24 months

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

KGOG3017

NCT ID:

NCT01570582

Start Date:

March 2010

Completion Date:

March 2014

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • recurrent ovarian
  • ECG
  • GOG performance
  • Hematologic g
  • Blood chemistry and urinalysis h
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

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