Know Cancer

or
forgot password

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
N/A
Not Enrolling
Female
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


OBJECTIVES:

Primary

- 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
dasatinib.

Secondary

- 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


DISEASE CHARACTERISTICS:

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

- 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
disease

- 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

PATIENT CHARACTERISTICS:

- 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
infection)

- 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
following:

- 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

PRIOR CONCURRENT THERAPY:

- 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
allowed

- 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
cancer

- 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:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month progression-free survival (PFS) rate

Safety Issue:

No

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000594930

NCT ID:

NCT00671788

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Sarasota Memorial HospitalSarasota, Florida  34239
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
AnMed Cancer CenterAnderson, South Carolina  29621
Women's Cancer Care AssociatesAlbany, New York  12208