Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer

Description

RATIONALE: Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with liposomal doxorubicin hydrochloride may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and the best dose of veliparib when given together with liposomal doxorubicin hydrochloride in patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer or metastatic breast cancer.

Study Start Date

June 2010

Estimated Completion Date

October 2016

Interventions

  • Drug: Veliparib
  • Drug: pegylated liposomal doxorubicin hydrochloride
  • Drug: veliparib
  • Other: Laboratory Biomarker Analysis
  • Drug: Pegylated Liposomal Doxorubicin Hydrochloride
  • Other: Pharmacological Study
  • Other: laboratory biomarker analysis
  • Other: pharmacological study

Specialties

  • Obstetrics & Gynecology: Breast,Clinical Pharmacology,Gynecologic Oncology
  • Oncology: Breast,Gynecologic Oncology,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Breast Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms

Study ID

National Cancer Institute (NCI) -- CDR0000674917

Status

Unknown

Trial ID

NCT01145430

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

58

Sponsor

National Cancer Institute (NCI)

DISEASE CHARACTERISTICS:
  • Histologically confirmed diagnosis of 1 of the following:
  • Recurrent or residual epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma
  • Metastatic breast cancer meeting the following criteria:
  • Estrogen-receptor negative
  • Progesterone-receptor negative
  • HER2/neu negative
  • Must meet 1 of the following criteria:
  • Non-measurable and/or measurable disease by RECIST
  • Abnormal CA-125 levels (in patients with ovarian cancer) >= 1.5 times normal documented by 2 independent measurements >= 4 weeks apart
  • Ovarian cancer patients with no prior pegylated liposomal doxorubicin hydrochloride (PLDH) must have failed <= 2 prior platinum-containing chemotherapy regimens
  • Patients who have had prior PLDH allowed provided they had >= 3 courses without grade 3 or 4 skin toxicity and have not had progressive disease
  • No patients who received prior filgrastim in order to receive prior PLDH
  • At least 2 prior chemotherapy regimens for metastatic breast cancer allowed
  • No prior PLDH
  • No known CNS metastases with active symptoms or requiring anticonvulsive medications or steroids PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Menopausal status not specified
  • ANC >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Creatinine <= 1.5 mg/dL
  • Total bilirubin <= 1.5 times upper limit of normal (ULN)
  • AST and ALT <= 3 times ULN (<= 5 times ULN if evidence of liver metastasis)
  • Ability to tolerate oral medications
  • LVEF normal
  • Fertile patients must use effective contraception before and during study participation
  • Not pregnant or nursing
  • No prior non-gynecologic malignancy within the past 5 years except nonmelanoma skin cancer or curatively treated stage I-III breast cancer (in the non-BRCA mutation stratum)
  • No active severe infection, including known infection with HIV, hepatitis B or C virus, or severe concurrent illness
  • No other non-malignant intercurrent illness (e.g., cardiovascular, pulmonary, central nervous system disease) that is either poorly controlled with currently available treatment or so severe that the investigators deem it unwise to enter the patient on protocol
  • No history of seizure disorders requiring antiepileptics or seizure episode within the past 6 months
  • No evidence of complete or partial bowel obstruction PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin C) and recovered
  • At least 3 weeks since prior investigational agents
  • No prior radiotherapy to the whole pelvis or greater amount of marrow-forming bone
  • Gender

    Both

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (8)

    Study Location Distance Name Phone Email
    Montefiore Medical CenterEinstein Campus - Bronx, New York 40.3 miles None None None
    Columbia UniversityHerbert Irving Cancer Center - New York, New York 44.8 miles Dawn L Hershman 212-305-1945 dlh23@columbia.edu
    Columbia UniversityHerbert Irving Cancer Center - New York, New York 44.8 miles None None None
    Mount Sinai Medical Center - New York, New York 46.8 miles None None None
    Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York, New York 50.2 miles Bhavana Pothuri 212-731-5345 bhavana.pothuri@nyumc.org
    Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York, New York 50.2 miles None None None
    Weill Medical College of Cornell University - New York, New York 50.7 miles Linda T Vahdat 212-821-0644 ltv2001@med.cornell.edu
    Weill Medical College of Cornell University - New York, New York 50.7 miles None None None

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