A Phase III Study of Olaparib vs Placebo as Maintenance Therapy in Women with BRCA-Mutated Advanced Ovarian Cancer After Platinum-Based Chemotherapy

Protocol
14-036
Full Title
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy (GOG 3004)
Phase
III
Purpose

Platinum-based chemotherapy, such as cisplatin or carboplatin, is standard treatment for advanced ovarian cancer. However, even in cancers that initially shrink with this therapy, the cancer often comes back. Usually, no treatment is given after the chemotherapy unless the cancer comes back. In this study, researchers want to see if giving patients with BRCA-mutated advanced ovarian cancer the drug olaparib after they finish platinum-based chemotherapy reduces the chance that their cancer will return.

Olaparib kills cancer cells by blocking the PARP protein, thereby preventing the repair of DNA or genetic damage in cancer cells. It is approved for treating some women with ovarian cancer. Olaparib is taken orally (by mouth).

Patients in this study will be randomly assigned to one of two groups. Two-thirds of the patients will receive olaparib, and one-third will receive a placebo. Patients will be tested to see if they have BRCA mutations. Cancer cells for these mutations are especially sensitive to olaparib.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have BRCA-mutated advanced ovarian cancer (stage III or IV) that shrank with a regimen of platinum-based chemotherapy.
  • Patients must have a BRCA1 or BRCA2 mutation. Patients will be tested for BRCA mutations, if they have not already been tested.
  • Patients must be enrolled within 8 weeks of the last dose of chemotherapy.
  • Patients may not have previously received a PARP inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Katherine M. Bell-McGuinn at 646-888-4221.

Disease(s)
Ovarian Cancer
Locations
Related Diseases