Brief Summary

This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.

Conditions

• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube High Grade Serous Adenocarcinoma
• Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor
• FIGO Stage III Ovarian Cancer 2014
• FIGO Stage IV Ovarian Cancer 2014
• Ovarian Carcinoma
• Ovarian Carcinosarcoma
• Ovarian High Grade Endometrioid Adenocarcinoma
• Ovarian High Grade Serous Adenocarcinoma
• Primary Peritoneal Carcinosarcoma
• Primary Peritoneal Endometrioid Adenocarcinoma
• Primary Peritoneal High Grade Serous Adenocarcinoma

Intervention / Treatment

• Biological: Bevacizumab
• Procedure: Biospecimen Collection
• Procedure: Computed Tomography
• Procedure: Magnetic Resonance Imaging
• Drug: Olaparib

Primary Outcome Measures

• Progression free survival (PFS) at least 360 days after randomization (PFS360) (From completing 360 days of maintenance therapy to disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) or death, whichever occurs first, assessed up to 5 years)
  PFS will be tested using a one-sided, alpha = 0.05 level logrank test. Treatment hazard ratios and their 90% confidence intervals will be estimated using a Cox proportional hazards model specified with a main effect for the randomized treatment assignment and stratified using the stratification factors applied at randomization.

Countries

Japan, Puerto Rico, United States

Locations and Investigators

• University of Alabama at Birmingham Cancer Center, Birmingham, United States (Recruiting)
  • Site Public Contact
  • Rebecca C. Arend (Principal Investigator)
• Anchorage Associates in Radiation Medicine, Anchorage, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Alaska Breast Care and Surgery LLC, Anchorage, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Alaska Oncology and Hematology LLC, Anchorage, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Alaska Women's Cancer Care, Anchorage, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Katmai Oncology Group, Anchorage, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Providence Alaska Medical Center, Anchorage, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Fairbanks Memorial Hospital, Fairbanks, United States (Recruiting)
  • Site Public Contact
  • John M. Schallenkamp (Principal Investigator)
• Cancer Center at Saint Joseph's, Phoenix, United States (Recruiting)
  • Site Public Contact
  • Shahzad Siddique (Principal Investigator)
• Mayo Clinic Hospital in Arizona, Phoenix, United States (Recruiting)
  • Site Public Contact
  • Siddhartha Yadav (Principal Investigator)
• Highlands Oncology Group - Fayetteville, Fayetteville, United States (Recruiting)
  • Site Public Contact
  • Joseph T. Beck (Principal Investigator)
• Mercy Hospital Fort Smith, Fort Smith, United States (Recruiting)
  • Site Public Contact
  • Jay W. Carlson (Principal Investigator)
• CARTI Cancer Center, Little Rock, United States (Recruiting)
  • Site Public Contact
  • Jay W. Carlson (Principal Investigator)
• University of Arkansas for Medical Sciences, Little Rock, United States (Recruiting)
  • Site Public Contact
  • Michael J. Birrer (Principal Investigator)
• Highlands Oncology Group - Rogers, Rogers, United States (Recruiting)
  • Site Public Contact
  • Joseph T. Beck (Principal Investigator)
• Highlands Oncology Group, Springdale, United States (Recruiting)
  • Site Public Contact
  • Joseph T. Beck (Principal Investigator)
• Kaiser Permanente-Deer Valley Medical Center, Antioch, United States (Recruiting)
  • Site Public Contact
  • Juraj Kavecansky (Principal Investigator)
• Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, United States (Recruiting)
  • Site Public Contact
  • Shahzad Siddique (Principal Investigator)
• Sutter Auburn Faith Hospital, Auburn, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Kaiser Permanente-Bellflower, Bellflower, United States (Recruiting)
  • Site Public Contact
  • Devansu Tewari (Principal Investigator)
• Alta Bates Summit Medical Center-Herrick Campus, Berkeley, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Tower Cancer Research Foundation, Beverly Hills, United States (Active not recruiting)
• Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, United States (Recruiting)
  • Site Public Contact
  • Dan S. Zuckerman (Principal Investigator)
• Mills-Peninsula Medical Center, Burlingame, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Mercy Cancer Center - Carmichael, Carmichael, United States (Recruiting)
  • Site Public Contact
  • Shahzad Siddique (Principal Investigator)
• Mercy San Juan Medical Center, Carmichael, United States (Recruiting)
  • Site Public Contact
  • Shahzad Siddique (Principal Investigator)
• Eden Hospital Medical Center, Castro Valley, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Sutter Davis Hospital, Davis, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Kaiser Permanente Dublin, Dublin, United States (Recruiting)
  • Site Public Contact
  • Juraj Kavecansky (Principal Investigator)
• Mercy Cancer Center - Elk Grove, Elk Grove, United States (Recruiting)
  • Site Public Contact
  • Shahzad Siddique (Principal Investigator)
• Stanford Cancer Center Emeryville, Emeryville, United States (Recruiting)
  • Site Public Contact
  • Kristin L. Bixel (Principal Investigator)
• Kaiser Permanente-Fremont, Fremont, United States (Recruiting)
  • Site Public Contact
  • Juraj Kavecansky (Principal Investigator)
• Palo Alto Medical Foundation-Fremont, Fremont, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Fresno Cancer Center, Fresno, United States (Recruiting)
  • Site Public Contact
  • Juraj Kavecansky (Principal Investigator)
• Kaiser Permanente Fresno Orchard Plaza, Fresno, United States (Recruiting)
  • Site Public Contact
  • Juraj Kavecansky (Principal Investigator)
• Kaiser Permanente-Fresno, Fresno, United States (Recruiting)
  • Site Public Contact
  • Juraj Kavecansky (Principal Investigator)
• Kaiser Permanente South Bay, Harbor City, United States (Recruiting)
  • Site Public Contact
  • Devansu Tewari (Principal Investigator)
• Kaiser Permanente-Irvine, Irvine, United States (Recruiting)
  • Site Public Contact
  • Devansu Tewari (Principal Investigator)
• UC San Diego Moores Cancer Center, La Jolla, United States (Recruiting)
  • Site Public Contact
  • Ramez N. Eskander (Principal Investigator)
• Kaiser Permanente Los Angeles Medical Center, Los Angeles, United States (Recruiting)
  • Site Public Contact
  • Devansu Tewari (Principal Investigator)
• Kaiser Permanente West Los Angeles, Los Angeles, United States (Recruiting)
  • Site Public Contact
  • Devansu Tewari (Principal Investigator)
• Cedars-Sinai Medical Center, Los Angeles, United States (Active not recruiting)
• Mercy Cancer Center, Merced, United States (Recruiting)
  • Site Public Contact
  • Shahzad Siddique (Principal Investigator)
• Memorial Medical Center, Modesto, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Kaiser Permanente- Modesto MOB II, Modesto, United States (Recruiting)
  • Site Public Contact
  • Juraj Kavecansky (Principal Investigator)
• Kaiser Permanente-Modesto, Modesto, United States (Recruiting)
  • Site Public Contact
  • Juraj Kavecansky (Principal Investigator)
• Palo Alto Medical Foundation-Camino Division, Mountain View, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)
• Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, United States (Recruiting)
  • Site Public Contact
  • John K. Chan (Principal Investigator)

And 645 other sites.

Study Officials

• Ying Liu (Principal Investigator) — NRG Oncology