Interaction of Docetaxel and Lonafarnib in Patients With Advanced Cancer
NCT ID: NCT00288444
Last Updated: 2012-12-18
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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TERMINATED
PHASE1
38 participants
INTERVENTIONAL
2006-01-31
2009-03-31
Brief Summary
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Detailed Description
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2. To determine the pharmacokinetic interaction between docetaxel and lonafarnib.
3. To determine the molecular interaction in peripheral blood mononuclear cells between docetaxel and lonafarnib
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Docetaxel 36 mg/ m2 IV weekly and Lonafarnib 150 mg
Docetaxel 36 mg/ m\^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
Lonafarnib
Docetaxel
Docetaxel 30 mg/ m2and Lonafarnib 150 mg
Docetaxel 30 mg/ m\^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
Lonafarnib
Docetaxel
Docetaxel 36 mg/ m2 and Lonafarnib 100 mg
Docetaxel 36 mg/ m\^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily
Lonafarnib
Docetaxel
Docetaxel 30 mg/m2 and Lonafarnib 100 mg
Docetaxel30 mg/m\^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily.
Lonafarnib
Docetaxel
Interventions
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Lonafarnib
Docetaxel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
3.1.3 Patient must have an ECOG performance status of 2 or less.
3.1.4 Patient must have a life-expectancy of at least 12 weeks.
3.1.5 Patient must have adequate bone marrow function: WBC ≥ 3,000 cells/mm3, ANC ≥ 1,500 cells/mm3, platelet count ≥ 100,000/mm3 and Hgb ≥ 9.0 g/dL.
3.1.6 Patient must have adequate liver function: total bilirubin level ≤ 2.0 mg/dL and ≤ ULN, albumin ≥ 2.5 g/dL.
3.1.7 Patient must have adequate renal function: Transaminases/Alkaline phosphatase: AST or ALT and alkaline phosphatase must be within the range allowing for eligibility. This range is defined as ≤ 2 x ULN.
In determining eligibility, the more abnormal of the two (AST or ALT) should be used.
3.1.8 Patient must have received no more than three previous chemotherapy regimens (prior chemotherapy may or may not have contained a taxane).
3.1.9 Patient must meet the specified informed consent requirement.
3.1.10 Patient must be of age ≥ 18 years.
3.1.11 Women of childbearing age must have a negative pregnancy test.
3.1.12 Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
3.1.13 Patient must have ≤ Grade 1 neurotoxicity from previous anticancer treatment or from any cause.
3.1.14 Patient must have adequate coagulation function: INR and PTT ≤ 1.5 x ULN.
3.1.15 Patient must have discontinued all prior chemotherapy and radiotherapy at least 4 weeks prior to registration.
3.1.16 Patient must have discontinued use of the following drugs which are an inducers or inhibitors of CYP3A4 at least 2 days prior to registration: ethinylestradiol, gestodene, itraconazole, ketoconazole, cimetidine, erythromycin, carbamazepine, high dose chronic steroids, phenobarbital, phenytoin, rifampin (rifampcin), and sulfinpyrazone.
Patient must have a pathologically-confirmed
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Exclusion Criteria
3.2.2 Patient is pregnant or breast feeding.
3.2.3 Patient has signs of symptoms of acute infection requiring systemic therapy.
3.2.4 Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair the patient's understanding of the informed consent.
3.2.5 Patient's life expectancy is less than 12 weeks.
3.2.6 Patient has \> Grade 1 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause.
3.2.7 Patient requires total parenteral nutrition with lipids.
3.2.8 Inability to swallow the lonafarnib BID.
3.2.9 Patient has a history of uncontrolled heart disease (including clinically significant coronary artery disease, congestive heart failure and symptomatic or uncontrolled arrythmias).
3.2.10 Patient has a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. Symptoms include: any reaction such as bronchospasm, generalized urticaria, systolic BP ≤ 80mm Hg, and angioedema.
3.2.11 Use of chronic steroids or anticonvulsants.
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ALL
No
Sponsors
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Aventis Pharmaceuticals
INDUSTRY
Schering-Plough
INDUSTRY
Emory University
OTHER
Responsible Party
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John Kauh
MD
Principal Investigators
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John Kauh, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Other Identifiers
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EU841-03
Identifier Type: -
Identifier Source: secondary_id
174-2004
Identifier Type: -
Identifier Source: org_study_id