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Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer

A Phase I Trial of the Combination of the PARP Inhibitor ABT-888 With Intraperitoneal Floxuridine (FUDR) in Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancers

NCT01749397•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of veliparib when given together with floxuridine in treating patients with epithelial ovarian, primary peritoneal cavity, or fallopian tube cancer that has spread to other places in the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with floxuridine may kill more tumor cells.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of the combination of ABT-888 (veliparib) and intraperitoneal (IP) floxuridine in adult patients with advanced ovarian, primary peritoneal or fallopian tube cancer. SECONDARY OBJECTIVES: I. To describe the adverse event profile associated with this treatment combination. II. To assess for preliminary evidence of efficacy, such as tumor responses, of the treatment combination. III. To assess progression free survival (PFS) in the maximum tolerated dose (MTD) cohort. TERTIARY OBJECTIVES: I. Assess the pharmacokinetic profile of ABT-888 and floxuridine when given in combination. II. Assess whether the presence of mutations in the homologous recombination pathway or loss of expression of non-homologous end joining (NHEJ) components correlates with response to floxuridine + ABT-888. OUTLINE: This is a dose-escalation study of veliparib. Patients receive veliparib orally (PO) twice daily (BID) on days 1-10 and floxuridine IP on days 3-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 months.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed epithelial ovarian, primary peritoneal or fallopian tube malignancy that is metastatic and for which standard curative measures do not exist
•EXPANSION PHASE ONLY: Evaluable or measurable disease with the largest nodule measuring less than 5 cm in greatest dimension by radiographic imaging after debulking procedure
•Candidate for and willingness to have a surgically placed intraperitoneal catheter and tissue acquisition at the time of port placement; note: if an intraperitoneal catheter is already in place, a tumor biopsy will still be required; a guided core-needle biopsy is sufficient in these cases
•Able to swallow and absorb the medication
•Obtained =\< 7 days prior to registration: Absolute neutrophil count (ANC) \>= 1500/mm\^3
•Obtained =\< 7 days prior to registration: Platelets (PLT) \>= 100,000/mm\^3
•Obtained =\< 7 days prior to registration: Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
•Obtained =\< 7 days prior to registration: Creatinine =\< 1.5 x institutional ULN
•Obtained =\< 7 days prior to registration: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 3 x institutional ULN
•Obtained =\< 7 days prior to registration: Hemoglobin (Hgb) \> 9.0 mg/dl
+4 more criteria

Exclusion Criteria

•Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy; note: patients with recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube will be allowed, if the investigator believes the study treatment is a better alternative to initiation platinum-based chemotherapy, such as patients with a prior platinum allergy or low volume disease for whom platinum-based therapy is deferred until a later date
•More than 4 prior chemotherapy regimens; note: repeat use of regimens count as 1 prior regimen; switching front-line therapy regimens (for example, from intraperitoneal to intravenous therapy) for reasons other than progression will count as 1 prior therapy; bevacizumab and other 'targeted' agents will count in the total number of prior regimens; vaccine therapies will not count in the total of prior therapies
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Any of the following prior therapies:
•* Chemotherapy =\< 28 days prior to registration
•* Mitomycin C/nitrosoureas =\< 42 days prior to registration
•* Immunotherapy =\< 28 days prior to registration
•* Biologic therapy =\< 28 days prior to registration
•* Radiation therapy =\< 28 days prior to registration
•* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\] approved indication and in the context of a research investigation) =\< 28 days prior to registration
+13 more criteria

Locations (5)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Siteman Cancer Center at Washington University

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

December 7, 2012

Primary Completion Date

October 20, 2017

Completion Date

November 21, 2019

Last Updated

July 2, 2020

Enrollment

ACTUAL participants

Conditions

Stage IV Fallopian Tube Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7Stage IV Primary Peritoneal Cancer AJCC v7

Interventions

Floxuridine

DRUG

Laboratory Biomarker Analysis

OTHER

Pharmacological Study

OTHER

Veliparib

DRUG

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

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ACTIVE_NOT_RECRUITINGPHASE3

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

NCT01167712

Fallopian Tube Endometrioid AdenocarcinomaFallopian Tube Mucinous Adenocarcinoma+28 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer

Inclusion Criteria

Exclusion Criteria

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Talazoparib in Determining Genetic Effects on Disease Response in Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Propranolol Hydrochloride and Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer