Know Cancer

or
forgot password

A Phase I/II Safety, Pharmacodynamic, and Pharmacokinetic Study of Intravenously Administered PXD101 Plus Carboplatin or Paclitaxel or Both in Patients With Advanced Solid Tumours


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer

Thank you

Trial Information

A Phase I/II Safety, Pharmacodynamic, and Pharmacokinetic Study of Intravenously Administered PXD101 Plus Carboplatin or Paclitaxel or Both in Patients With Advanced Solid Tumours


MTD Expansion I(Phase II): A total of 18-32 patients with epithelial ovarian, primary
peritoneal, fallopian tube or mixed mullerian tumours of ovarian origin, in need of relapse
treatment will be enrolled.

MTD Expansion II (phase II): A total of 15 patients with urothelial (transitional cell)
carcinoma of the bladder will be enrolled.


Inclusion Criteria:



- Ovarian patients:

-- Patients with epithelial ovarian, primary peritoneal, fallopian tube or mixed
mullerian cancer of ovarian origin in need of relapse treatment

- Bladder patients:

-- Patients with urothelial (transitional cell) cancer of the bladder

- All Patients:

- At least one measurable uni-dimensional lesion

- ECOG (Eastern Cooperative Oncology Group) status ≤ 2

- Life expectancy ≥ 3 months

- Age ≥ 18 years

- Acceptable liver, renal and bone marrow function:

- Bilirubin ≤ 1.5 x ULN (upper limit of normal)

- AST (SGOT) (aspartate aminotransferase), ALT (SGPT) (alanine
aminotransferase)and Alkaline Phosphatase ≤ 3 x ULN. If liver metastases
are present then ≤ 5 x ULN is allowed.

- Measured EDTA (ethylenediaminetetraacetic acid) renal clearance ≥ 45 mL/min
(within EU).

- Creatinine clearance ≥ 45 mL/min (within USA)

- Leucocytes > 2.5 x 109/ L

- Neutrophils > 1.0 x 109/L

- Platelets > 100 x 109/L

- Hemoglobin > 9.0 g/dL or > 5.6 mmol/l

- Acceptable coagulation status

- Negative pregnancy test/use of effective contraceptive methods for women of
childbearing potential.

- Serum potassium within normal range

Exclusion Criteria:

- More than three prior lines of chemotherapy given for metastatic disease

- History of a concurrent second malignancy

- History of hypersensitivity to either platinum or paclitaxel that cannot be
desensitized

- Co-existing active infection or any co-existing medical condition likely to interfere
with trial procedures, including:

- significant cardiovascular disease (New York Heart Association Class III or IV
cardiac disease)

- myocardial infarction within the past 6 months

- unstable angina

- congestive heart failure requiring therapy

- unstable arrhythmia or a need for anti-arrhythmic therapy

- evidence of ischemia on ECG

- marked baseline prolongation of QT/QTc ((corrected)QT interval) interval, e.g.,
repeated demonstration of a QTc interval > 500 msec;

- long QT Syndrome

- required use of concomitant medication on PXD101 infusion days that may cause
Torsade de Pointes.

- Bowel obstruction or impending bowel obstruction

- Known HIV positivity

- Mixed mullerian cancer of intra-uterine origin

- Any existing grade 2 or above drug-related neurotoxicity due to prior treatment with
agents causing neurotoxicity

- Altered mental status precluding understanding of the informed consent process and/or
completion of the necessary studies

- Treatment with investigational agents within the last 4 weeks

- Prior anticancer therapy within the last 3 weeks of trial dosing including
chemotherapy, radiotherapy, endocrine therapy or immunotherapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose and dose limiting toxicities of belinostat (PXD101) administered in combination with standard doses of carboplatin or paclitaxel or both.

Outcome Time Frame:

throughout the study

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PXD101-CLN-8

NCT ID:

NCT00421889

Start Date:

August 2005

Completion Date:

February 2009

Related Keywords:

  • Ovarian Cancer
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Ovarian cancer
  • Ovarian Neoplasms
  • Primary peritoneal
  • Epithelial ovarian
  • Fallopian tube
  • belinostat
  • PXD101
  • mixed mullerian cancer of ovarian origin
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Gynecologic Oncology AssociatesNewport Beach, California  92663
Hematology and Oncology Specialists, LLCNew Orleans, Louisiana  70115
Research FacilityOrlando, Florida  32804
Hematology & Oncology Specialists, LLCMetairie, Louisiana  70006
Women & Infants Hospital of Rhode IslandProvidence, Rhode Island  02905