A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer & Papillary Serous Mullerian Tumors
- Each treatment cycle lasts three weeks (21 days). Participants will receive only
paclitaxel and carboplatin on Day 1 of Cycle 1. They will receive paclitaxel,
carboplatin and Avastin for cycles 2-6. All of these drugs are given intravenously.
- After participants receive six cycles of treatment with paclitaxel and carboplatin,
they will be randomized into one of two study groups. Group 1 will receive treatment
with Avastin every 3 weeks for 1 year. Group 2 will receive Avastin every 3 weeks for
1 year and take erlotinib orally every day for 1 year. This second part will occur
about one month after the second look surgery (see below).
- If there is no cancer seen on a scan that is performed after 6 cycles of paclitaxel,
carboplatin and Avastin, second look surgery will be discussed. The second look
surgery is to see if there is any cancer at the end of treatment that was not seen by
CT scan or MRI. This surgery will take place about one month after the 6th cycle of
treatment if it is recommended.
- During all treatment cycles participants will have a physical exam and be asked
questions about their general health and specific questions about any problems they are
- Blood tests including chemistry, hematology, CA-125, as well as other tests to measure
any additional effect of the study drug or disease status, will be done prior to each
cycle of treatment and during the follow-up period.
- Assessment of the tumor by CT scan or MRI will be done as follows: After every three
cycles of chemotherapy; every three months during consolidation treatment (treatment
with Avastin OR Avastin and erlotinib); every three months after the end of study
treatment for 1 year, unless the tumor grows.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To examine the progression free survival of Avastin and erlotinib (AE) or Avastin (A) as consolidation therapy at predefined time.
Susana Campos, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|