Overview

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

Status:
Unknown status
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
Female
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Korean Gynecologic Oncology Group
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Gemcitabine
Paclitaxel
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.