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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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Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
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Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
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Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
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Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
University of Virginia Cancer Center Charlottesville, Virginia  22908
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
York Cancer Center at Apple Hill Medical Center York, Pennsylvania  17405
Saint Louis University Cancer Center Saint Louis, Missouri  63110
AnMed Cancer Center Anderson, South Carolina  29621
Women's Cancer Care Associates Albany, New York  12208