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A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma



- To estimate the 6-month progression-free survival (PFS) rate and objective tumor
response rate (complete or partial response) in patients with persistent or recurrent
ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with


- To determine the frequency and severity of adverse events as assessed by CTCAE v3.0.

- To determine the duration of PFS and overall survival.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib once daily 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 every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube

- Recurrent or persistent disease

- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest dimension to be recorded) as ≥ 20 mm by conventional techniques or
≥ 10 mm by spiral CT scan

- Has ≥ 1 target lesion to assess response

- Tumors within a previously irradiated field are considered non-target
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days following completion of radiotherapy

- Ineligible for a higher priority GOG protocol

- Must have received 1 prior platinum-based chemotherapeutic regimen containing
carboplatin, cisplatin, or other organoplatinum compound for management of primary

- Initial treatment may have included intraperitoneal therapy, high-dose therapy,
consolidation therapy, non-cytotoxic agents, or extended therapy administered
after surgical or non-surgical assessment

- One additional cytotoxic regimen for recurrent or persistent disease allowed

- Disease progression during therapy OR disease persistence after completion of
therapy OR platinum-free interval < 12 months

- No active pleural or pericardial effusion of any grade


- GOG performance status (PS) 0-2 (for patients who received 1 prior regimen) OR PS 0-1
(for patients who received 2 prior regimens)

- Able to swallow whole pills

- ANC ≥ 1,500/mcL

- Platelet count ≥ 100,000/mcL

- Hemoglobin ≥ 10 g/dL

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Magnesium, calcium, phosphate, potassium, and sodium corrected to normal

- No hypokalemia or hypomagnesemia that cannot be corrected to normal

- PT/INR ≤ 1.5 times ULN

- PTT ≤ 1.5 times ULN

- Neuropathy (sensory and motor) ≤ grade 1

- QTc interval ≤ 450 msec on ECG

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 4 weeks after
completion of study treatment

- No active infection requiring antibiotics (except uncomplicated urinary tract

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- No history of cardiac disease, including any of the following:

- Uncontrolled angina, congestive heart failure, or myocardial infarction within
the past 6 months

- Diagnosed congenital long QT syndrome

- Clinically significant ventricular arrhythmias (e.g., ventricular tachycardia,
ventricular fibrillation, or Torsades de pointes)

- No history of significant bleeding disorder unrelated to cancer, including any of the

- Bleeding diathesis, congenital or acquired, (e.g., von Willebrand's disease,
acquired anti-factor VIII antibodies) within the past year

- Significant gastrointestinal bleeding within the past 3 months


- See Disease Characteristics

- Recovered from prior surgery, radiotherapy, or chemotherapy

- At least 7 days since prior drugs known to prolong the QT interval, including any of
the following:

- Quinidine, procainamide, disopyramide

- Amiodarone, sotalol, ibutilide, dofetilide

- Erythromycin, clarithromycin

- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- Concurrent hormone replacement therapy allowed

- At least 3 weeks since other prior therapy directed at the malignant tumor, including
immunologic agents

- At least 6 weeks since prior monoclonal antibodies

- No prior dasatinib

- No prior noncytotoxic therapy for recurrent or persistent disease

- Prior biologic (noncytotoxic) therapy as part of primary treatment regimen

- No prior cancer treatment that contraindicates study treatment

- No prior radiotherapy to > 25% of marrow-bearing areas

- More than 5 years since prior radiotherapy to any portion of the abdominal cavity or
pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is
allowed provided it was completed more than 3 years ago and the patient remains
free of recurrent or metastatic disease

- More than 5 years since prior chemotherapy for any abdominal or pelvic tumor other
than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

- Prior adjuvant chemotherapy for localized breast cancer allowed provided it was
completed more than 3 years ago and the patient remains free of recurrent or
metastatic disease

- At least 5 days since prior and no concurrent Hypericum perforatum (St. John's wort)

- At least 7 days since prior and no concurrent potent CYP3A4 inhibitors (e.g.,
ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, atazanavir,
indinavir, nefazodone, nelfinavir, saquinavir, telithromycin)

- Concurrent warfarin for prophylaxis or treatment of thrombosis allowed

- Concurrent low molecular weight heparin is allowed provided PT/INR ≤ 1.5

- No IV bisphosphonates during the first 8 weeks of study treatment

- No concurrent amifostine or other protective reagents

- No concurrent grapefruit juice

- No concurrent H2 blockers or proton pump inhibitors (e.g., famotidine, omeprazole)

- No other concurrent investigational agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month progression-free survival (PFS) rate

Safety Issue:


Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2008

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



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