Rucaparib in Treating Patients with Stage III, IV or Endometrial Cancer That Has Either Spread or Has Come Back After Prior Treatment
This phase II trial studies how well rucaparib works in treating patients with stage III or IV endometrial cancer that has either spread or has come back after prior treatment. Rucaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Inclusion Criteria
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a female aged 18-89
- Patients with a primary stage III/IV or recurrent endometrial cancer
- Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy)
- Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles
- Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy
- Patients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks’ time elapse prior to initiation of drug
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Absolute Neutrophil Count (ANC) >= 1500 cells/uL
- Platelet count > 100,000 uL
- Hemoglobin >= 9.0 g/dL
- Serum albumin >= 2.5 g/dL
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and Alanine transaminase (ALT) =< 3.0 x ULN
- Serum creatinine =< 1.5 x ULN
Exclusion Criteria
- Inability to comply with study and follow-up procedures
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (class II or greater), myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina
- AST and ALT > 3.0 x ULN
- Total bilirubin >= 1.5 x ULN
- Documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease
- Participation in investigational clinical trial within last 30 days
- History of significant chronic disease including human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) or hepatitis C
- Inability to provide informed consent
- Known central nervous system (CNS) malignancy or CNS metastases
- Patients with previous malignancy, other than endometrial, within the past 2 years from cycle 1, day 1, with the exception of those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast
- History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1 (C1D1)
- Major surgical procedure within 28 days prior to C1D1 or anticipation of needing a major surgical procedure during the course of the study
- Women with prognosis for survival less than 6 months
- Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen
- Patients deemed otherwise clinically unfit for clinical trial per investigator’s discretion
- Patients with duodenal stent or other gastrointestinal (GI) disorder/defect that would interfere with absorption of oral medication
- Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing
- Non-study related minor surgical procedure =< 5 days or major surgeries =< 21 days prior to first dose of treatment
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03617679.
PRIMARY OBJECTIVES:
I. To measure progression free survival (PFS) with the use of rucaparib camsylate (rucaparib) compared to placebo in women with recurrent or metastatic endometrial cancer after first line chemotherapy.
SECONDARY OBJECTIVES:
I. To measure overall survival (OS) with the use of rucaparib compared to placebo in women with recurrent or metastatic endometrial cancer after first line chemotherapy.
II. To determine the efficacy with the use of rucaparib compared to placebo in women with recurrent or metastatic endometrial cancer after first line chemotherapy as measured by overall response rate (ORR) in patients with measurable disease.
III. Safety and tolerability.
TERTIARY/EXPLORATORY OBJECTIVES:
I. To preliminarily assess the efficacy with the use of rucaparib compared to placebo in women with recurrent or metastatic endometrial cancer after first line chemotherapy in relation to HRD, BRCA, PTEN, PIK3CA and AKT.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive rucaparib camsylate orally (PO) twice daily (BID) on days 1- 28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive placebo PO BID on days 1- 28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up annually.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorBradley Robert Corr
- Primary ID18-0567
- Secondary IDsNCI-2018-02063
- ClinicalTrials.gov IDNCT03617679