Dasatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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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 |
- 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 ]
- 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) |
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 |
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
Show 29 Study Locations| 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 May 21, 2013