Interaction of Docetaxel and Lonafarnib in Patients With Advanced Cancer
Defining the Interaction of Docetaxel and Lonafarnib in Patients With Advanced Malignancies
2 other identifiers
interventional
38
1 country
1
Brief Summary
To determine the molecular interaction in tumor samples between docetaxel and lonafarnib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 lung-cancer
Started Jan 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedDecember 18, 2012
December 1, 2012
2.3 years
February 6, 2006
December 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the molecular interaction
Four weeks
Secondary Outcomes (1)
Determine safety and efficacy
4 Weeks
Study Arms (4)
Docetaxel 36 mg/ m2 IV weekly and Lonafarnib 150 mg
ACTIVE COMPARATORDocetaxel 36 mg/ m\^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
Docetaxel 30 mg/ m2and Lonafarnib 150 mg
ACTIVE COMPARATORDocetaxel 30 mg/ m\^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
Docetaxel 36 mg/ m2 and Lonafarnib 100 mg
ACTIVE COMPARATORDocetaxel 36 mg/ m\^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily
Docetaxel 30 mg/m2 and Lonafarnib 100 mg
ACTIVE COMPARATORDocetaxel30 mg/m\^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily.
Interventions
Eligibility Criteria
You may qualify if:
- Only patients determined to be at minimal risk to receiving the biopsy (with tumor location/accessibility as well as underlying patient comorbidities judged to allow a minimal risk biopsy by the radiologist/surgeon performing the procedure) will be eligible for this study.
- Patient must have an ECOG performance status of 2 or less.
- Patient must have a life-expectancy of at least 12 weeks.
- 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.
- Patient must have adequate liver function: total bilirubin level ≤ 2.0 mg/dL and ≤ ULN, albumin ≥ 2.5 g/dL.
- 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.
- Patient must have received no more than three previous chemotherapy regimens (prior chemotherapy may or may not have contained a taxane).
- Patient must meet the specified informed consent requirement.
- Patient must be of age ≥ 18 years.
- Women of childbearing age must have a negative pregnancy test.
- 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.
- Patient must have ≤ Grade 1 neurotoxicity from previous anticancer treatment or from any cause.
- Patient must have adequate coagulation function: INR and PTT ≤ 1.5 x ULN.
- Patient must have discontinued all prior chemotherapy and radiotherapy at least 4 weeks prior to registration.
- +2 more criteria
You may not qualify if:
- Patient has received more than three previous chemotherapy regimens.
- Patient is pregnant or breast feeding.
- Patient has signs of symptoms of acute infection requiring systemic therapy.
- Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair the patient's understanding of the informed consent.
- Patient's life expectancy is less than 12 weeks.
- Patient has \> Grade 1 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause.
- Patient requires total parenteral nutrition with lipids.
- Inability to swallow the lonafarnib BID.
- Patient has a history of uncontrolled heart disease (including clinically significant coronary artery disease, congestive heart failure and symptomatic or uncontrolled arrythmias).
- 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.
- Use of chronic steroids or anticonvulsants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Aventis Pharmaceuticalscollaborator
- Schering-Ploughcollaborator
Study Sites (1)
Emory University Winship Cancer Institute
Atlanta, Georgia, 30308, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Kauh, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 8, 2006
Study Start
January 1, 2006
Primary Completion
May 1, 2008
Study Completion
March 1, 2009
Last Updated
December 18, 2012
Record last verified: 2012-12