Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Carcinomatosis
  • Advanced Fallopian Tube Carcinoma
  • Advanced Ovarian Carcinoma
  • Advanced Primary Peritoneal Carcinoma
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Stage IIIB Fallopian Tube Cancer AJCC v7
  • Stage IIIA Primary Peritoneal Cancer AJCC v7
  • Stage IV Primary Peritoneal Cancer AJCC v7
  • Primary Peritoneal High Grade Serous Adenocarcinoma
  • Stage IV Fallopian Tube Cancer AJCC v6 and v7
  • Stage III Fallopian Tube Cancer AJCC v7
  • Stage IIIB Ovarian Cancer AJCC v6 and v7
  • Stage IV Ovarian Cancer AJCC v6 and v7
  • Stage IIIB Primary Peritoneal Cancer AJCC v7
  • Stage IIIA Ovarian Cancer AJCC v6 and v7
  • Stage III Ovarian Cancer AJCC v6 and v7
  • Stage IIIC Fallopian Tube Cancer AJCC v7
  • Stage IIIC Ovarian Cancer AJCC v6 and v7
  • Stage III Primary Peritoneal Cancer AJCC v7
  • Stage IIIC Primary Peritoneal Cancer AJCC v7
  • Stage IIIA Fallopian Tube Cancer AJCC v7
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

PRIMARY OBJECTIVE: I. To explore baseline levels and effects of adavosertib (AZD1775) on DNA copy number, mutation, and level of ribonucleic acid (RNA) and protein expression (together described as "molecular results") in tumor protein p53 (p53)-related pathways before and after treatment in women w...

PRIMARY OBJECTIVE: I. To explore baseline levels and effects of adavosertib (AZD1775) on DNA copy number, mutation, and level of ribonucleic acid (RNA) and protein expression (together described as "molecular results") in tumor protein p53 (p53)-related pathways before and after treatment in women with primary advanced high grade serous ovarian, fallopian tube, or primary peritoneal cancer. SECONDARY OBJECTIVES: I. To correlate molecular results to clinical endpoints including response and survival. II. To correlate molecular results to pathologic endpoints including tumor volume and apoptosis. III. To compare DNA copy number and level of RNA and protein expression in p53-related pathways in tissue from patients treated with AZD1775 to those untreated with AZD1775 in the preoperative period. IV. To determine the toxicity of AZD1775 given preoperatively, with a focus on postoperative wound healing. V. To determine the feasibility of treating preoperatively with AZD1775. OUTLINE: Patients receive adavosertib orally (PO) once daily (QD) on days 1-5. Patients then undergo standard of care laparoscopy. Patients may also receive adavosertib PO QD on days 8-12, 15-19, and 22-26 for up to 28 days based on surgery schedule. After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

Tracking Information

NCT #
NCT02659241
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Shannon N Westin M.D. Anderson Cancer Center