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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:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00671788
First received: May 2, 2008
Last updated: July 24, 2014
Last verified: July 2014
  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 Gynecologic Oncology Group:

Primary Outcome Measures:
  • Progression-free Survival at 6 Months [ Time Frame: Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. ] [ Designated as safety issue: No ]

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.

    CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.


  • Tumor Response [ Time Frame: Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. ] [ Designated as safety issue: No ]

    Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.

    CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.



Secondary Outcome Measures:
  • Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0 [ Time Frame: Every cycle during treatment ] [ Designated as safety issue: Yes ]
  • Progression-free Survival [ Time Frame: Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. ] [ Designated as safety issue: No ]

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.

    CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.


  • Overall Survival [ Time Frame: Every other cycle up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 2008
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dasatinib
Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening.
Drug: dasatinib

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: GOG-0170M, CDR0000594930, NCI-2011-03824
Study First Received: May 2, 2008
Results First Received: January 31, 2014
Last Updated: July 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

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

ClinicalTrials.gov processed this record on November 25, 2014