Dasatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00671788
First received: May 2, 2008
Last updated: July 8, 2012
Last verified: January 2009
  Purpose

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: dasatinib
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 6-month progression-free survival (PFS) rate [ Designated as safety issue: No ]
  • Objective tumor response rate (complete or partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of adverse events as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Duration of PFS and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2008
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671788

  Show 29 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00671788     History of Changes
Other Study ID Numbers: CDR0000594930, GOG-0170M
Study First Received: May 2, 2008
Last Updated: July 8, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Abdominal Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014