PH I SRC Kinase, Dasatinib Combo Paclitaxel & Carboplatin in Pts w Ovarian, Peritoneal, & Tubal Cancer
NCT ID: NCT00672295
Last Updated: 2012-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2007-08-31
2012-11-30
Brief Summary
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Secondary objectives to describe the toxicity of this combination of therapy; to describe the pharmacokinetics and pharmacodynamics parameters related to this combination; to describe the clinical activity as defined as the response rate (complete and partial response rate) and progression-free survival \> 6 month; to compare the SRC pathway microarray signature in pre and post-treatment cancer specimens; to evaluate SRC pathway downstream substrates, FAX, paxcillin, and CRK-L in pre and post-treatment cancer specimens.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dasatinib, paclitaxel,and carboplatin
Combination of dasatinib, paclitaxel,and carboplatin
Dasatinib, Paclitaxel, and Carboplatin
Dasatinib will be administered as an oral dose (tablet) as per the dose escalation (50 mg everyday - 250 mg everyday)continuously on days 2-21 in the first cycle (3 weeks) therapy and continuously (days 1-21) throughout the remainder of therapy.
Paclitaxel will be administered on a 21-day schedule. Paclitaxel (150-175 mg/m\^2) IV infused over 3 hours on day #1 of each cycle.
Carboplatin (AUC=5-6 mg/,l/min) will be infused over 30-60 minutes every cycle via IV on day 1 of every cycle following the paclitaxel administration.
All patients will be followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years and data entered into eDC, unless is withdrawn.
Interventions
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Dasatinib, Paclitaxel, and Carboplatin
Dasatinib will be administered as an oral dose (tablet) as per the dose escalation (50 mg everyday - 250 mg everyday)continuously on days 2-21 in the first cycle (3 weeks) therapy and continuously (days 1-21) throughout the remainder of therapy.
Paclitaxel will be administered on a 21-day schedule. Paclitaxel (150-175 mg/m\^2) IV infused over 3 hours on day #1 of each cycle.
Carboplatin (AUC=5-6 mg/,l/min) will be infused over 30-60 minutes every cycle via IV on day 1 of every cycle following the paclitaxel administration.
All patients will be followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years and data entered into eDC, unless is withdrawn.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All pts must have measurable disease
* \> 18 yrs
* Expected survival of at least 3 months
* Pts must have GOG performance status pf 0, 1 or 2
* Pts must have adequate:Bone marrow function, renal function, hepatic function, neurologic function
* No chemo, radiotherapy, biologic, hormonal, or investigational drug therapy within 28 days prior to study entry
* Pts may have had up to 3 prior cytotoxic chemo regimens including prior treatment w carboplatin \& paclitaxel
* Capable of providing written informed consent
* Pts of childbearing potential must have negative serum pregnancy test prior to study entry \& be practicing effective method of birth control during course of study, in manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential must be advised of importance of avoiding pregnancy during trial participation \& potential risk factors for unintentional pregnancy
* Pts must have tissue block from their tumor available for evaluation for microarray \& immunoblot analyses. Pretreatment tumor tissue may be obtained from either archival tissue or be obtained by guided by guided core needle or simple biopsy it must be performed within four weeks prior to enrollment on study. Pts must have tumor that is accessible to biopsy \& consent to undergo post-treatment biopsy after cycle #2 of treatment as well
Exclusion Criteria
* Pts w history of other invasive malignancies, w exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within last 5 yrs
* Pts who have following cardiac conditions: uncontrolled angina or myocardial infarction within past 6 months; diagnosed or suspected congenital long QT syndrome; Any history of clinically significant ventricular arrhythmias; Prolonged QTc interval on pre-entry electrocardiogram on both Fridericia \& Bazett's correction; uncontrolled hypertension
* History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders; diagnosed acquired bleeding disorder within 1 yr
* Pts currently taking drugs that are generally accepted to have risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide; amiodarone, sotalol, ibutilide, dofetilide; erythromycins, clarithromycin; chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide; cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
* Serum creatinine \> 1.5 times institutional upper limits of normal
* Pts taking certain concomitant medications, consider following prohibitions: medications that inhibit platelet function or anticoagulants
* Pts who have received radiation therapy to \> 30 percent of bone marrow
* Pts w history of grade 3 hypersensitivity to paclitaxel or carboplatin
* Pts w septicemia, severe infection, acute hepatitis, other uncontrolled severe medical conditions
18 Years
FEMALE
No
Sponsors
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AA Secord
OTHER
Responsible Party
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AA Secord
Associate Professor, Gynecologic Oncology
Principal Investigators
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Angeles A Secord, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Duke University Health System
Durham, North Carolina, United States
Countries
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References
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Secord AA, Teoh DK, Barry WT, Yu M, Broadwater G, Havrilesky LJ, Lee PS, Berchuck A, Lancaster J, Wenham RM. A phase I trial of dasatinib, an SRC-family kinase inhibitor, in combination with paclitaxel and carboplatin in patients with advanced or recurrent ovarian cancer. Clin Cancer Res. 2012 Oct 1;18(19):5489-98. doi: 10.1158/1078-0432.CCR-12-0507. Epub 2012 Jul 26.
Related Links
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Related Info
Other Identifiers
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105821b
Identifier Type: -
Identifier Source: secondary_id
9311-06-R0
Identifier Type: -
Identifier Source: secondary_id
Pro00012282
Identifier Type: -
Identifier Source: org_study_id