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A Phase I Trial of A SRC Kinase Inhibitor, Dasatinib,in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Recurrent Ovarian, Peritoneal, and Tubal Cancer


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

Thank you

Trial Information

A Phase I Trial of A SRC Kinase Inhibitor, Dasatinib,in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Recurrent Ovarian, Peritoneal, and Tubal Cancer


This is a phase I multicenter study designed to determine the maximal tolerated dose (MTD)
and toxicity of dasatinib in combination with paclitaxel and carboplatin during the first
cycle of treatment in patients with advanced or recurrent ovarian, peritoneal, and tubal
carcinoma. The MTD will be defined as the highest dose at which no more than 1 of 6
evaluable patient experiences a dose-limiting toxicity (DLT) due to the combination of
dasatinib, paclitaxel,and carboplatin during the first cycle of treatment.


Inclusion Criteria:



- Pts must have histologic or cytologic evidence of ovarian, peritoneal, or tubal
cancer

- All pts must have measurable disease

- > 18 yrs

- Expected survival of at least 3 months

- Pts must have GOG performance status pf 0, 1 or 2

- Pts must have adequate:Bone marrow function, renal function, hepatic function,
neurologic function

- No chemo, radiotherapy, biologic, hormonal, or investigational drug therapy within 28
days prior to study entry

- Pts may have had up to 3 prior cytotoxic chemo regimens including prior treatment w
carboplatin & paclitaxel

- Capable of providing written informed consent

- Pts of childbearing potential must have negative serum pregnancy test prior to study
entry & be practicing effective method of birth control during course of study, in
manner such that risk of failure is minimized. Prior to study enrollment, women of
childbearing potential must be advised of importance of avoiding pregnancy during
trial participation & potential risk factors for unintentional pregnancy

- Pts must have tissue block from their tumor available for evaluation for microarray &
immunoblot analyses. Pretreatment tumor tissue may be obtained from either archival
tissue or be obtained by guided by guided core needle or simple biopsy it must be
performed within four weeks prior to enrollment on study. Pts must have tumor that is
accessible to biopsy & consent to undergo post-treatment biopsy after cycle #2 of
treatment as well

Exclusion Criteria:

- Pts w epithelial ovarian tumors of low malignant potential (borderline tumor)

- Pts w history of other invasive malignancies, w exception of non-melanoma skin
cancer, are excluded if there is any evidence of other malignancy being present
within last 5 yrs

- Pts who have following cardiac conditions: uncontrolled angina or myocardial
infarction within past 6 months; diagnosed or suspected congenital long QT syndrome;
Any history of clinically significant ventricular arrhythmias; Prolonged QTc interval
on pre-entry electrocardiogram on both Fridericia & Bazett's correction; uncontrolled
hypertension

- History of significant bleeding disorder unrelated to cancer, including: diagnosed
congenital bleeding disorders; diagnosed acquired bleeding disorder within 1 yr

- Pts currently taking drugs that are generally accepted to have risk of causing
Torsades de Pointes including: quinidine, procainamide, disopyramide; amiodarone,
sotalol, ibutilide, dofetilide; erythromycins, clarithromycin; chlorpromazine,
haloperidol, mesoridazine, thioridazine, pimozide; cisapride, bepridil, droperidol,
methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl,
pentamidine, sparfloxacin, lidoflazine

- Serum creatinine > 1.5 times institutional upper limits of normal

- Pts taking certain concomitant medications, consider following prohibitions:
medications that inhibit platelet function or anticoagulants

- Pts who have received radiation therapy to > 30 percent of bone marrow

- Pts w history of grade 3 hypersensitivity to paclitaxel or carboplatin

- Pts w septicemia, severe infection, acute hepatitis, other uncontrolled severe
medical conditions

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine maximal tolerated dose (MTD) of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Angeles A Secord, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System

Authority:

United States: Institutional Review Board

Study ID:

Pro00012282

NCT ID:

NCT00672295

Start Date:

August 2007

Completion Date:

November 2012

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Tubal Cancer
  • Fallopian Tube Cancer
  • Dasatinib
  • Sprycel
  • Paclitaxel
  • Taxol
  • Carboplatin
  • Paraplatin
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Moffitt Cancer CenterTampa, Florida  33612
Duke University Health SystemDurham, North Carolina  27705