| Ad Title: |
A Phase III Multicenter, Randomized, Blinded, Placebo-Controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinum-Sensitive Recurrent Ovary, Primary Peritoneal or Fallopian tube Carcinoma (OCEANS) |
| Study Title: |
Protocol AVF4095g: A Phase III, Multicenter, Randomized, Blinded, Placebo-Controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinum-Sensitive Recurrent Ovary, Primary Peritoneal or Fallopian Tube Carcinoma |
| Protocol Number: |
062007-075 |
| Department(s) involved in the Study: |
Obstetrics & Gynecology
|
| Purpose of the Study: |
To evaluate the efficacy of combining bevacizumab with carboplatin and gemcitabine compared with carboplatin and gemcitabine with placebo in patients with platinum-sensitve recurrent ovarian, parimary peritoneal, or fallopian tube cancer. Efficacy outcome measure is progression free survival where the date of progression is based on investigator assessment using the modified RECIST criteria. |
| Participant Eligibility: |
Must be age 18 and older with histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that has progressed or recurred > 6 months after platinum-based chemotherapy. This must be the first recurrence of epithelial ovarian, primary peritoneal, or fallopian tube carcinoma. Must have measurable disease according to RECIST, ECOG performance status 0-1, be greater than 28 days from and recovered from prior radiation therapy or surgery, use an effective means of contraception, sign informed consent, and comply with all study and follow up procedures. Spanish speaking patients are eligible to participate. |
| Disease/Condition Under Study: |
Recurrent ovarian, primary peritoneal or fallopian tube carcinoma |
| Cancer Related Study: |
Yes
|
| Study Drug(s): |
Avastin (Bevacizumab), Gemzar (Gemcitabine), Paraplatin (Carboplatin)
|
| Study Device(s): |
|
| Study Doctor: |
Dr. David Miller |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Parkland Memorial Hospital
|
Yes
|
|
Aston Ambulatory Care Center
|
Yes
|
|
UT Southwestern Medical Center
|
Yes
|
|
| Contact Phone: |
214-648-7031 |
| Email: |
stacy.foster@utsouthwestern.edu |
| Other Information: |
|
| Website Keywords: |
Gyn Oncology, Gynecology, Obstetrics, Reproductive, Women's Health
|
| Medical Keywords: |
Fallopian Tube Carcinoma, Ovarian Cancer, Primary Peritoneal Cancer
|
