Lung CancerPhase 1NCT00288444
Interaction of Docetaxel and Lonafarnib in Patients With Advanced Cancer
A Phase 1 study testing Lonafarnib and Docetaxel in people with Lung Cancer and Soft Tissue Sarcoma, run by Emory University at 1 site in United States.
Trial summary
To determine the molecular interaction in tumor samples between docetaxel and lonafarnib. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Soft Tissue Sarcoma, Colorectal Carcinoma
- What is being tested?
- Lonafarnib and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 3.2.1 Patient has received more than three previous chemotherapy regimens.
- 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.
Show all 12Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30308
About this study
Official title: Defining the Interaction of Docetaxel and Lonafarnib in Patients With Advanced Malignancies
To determine the molecular interaction in tumor samples between docetaxel and lonafarnib.
Read the detailed description
- To determine the safety and toxicity of intravenous docetaxel, administered on a weekly schedule (3 weeks out of 4), in combination with oral lonafarnib, administered on a daily schedule, in patients with locally advanced and metastatic solid tumor malignancies which are refractory to the standard of care.
- To determine the pharmacokinetic interaction between docetaxel and lonafarnib.
- To determine the molecular interaction in peripheral blood mononuclear cells between docetaxel and lonafarnib
- Being tested
- Lonafarnib, Docetaxel
- Keywords
- Advanced malignancies.
- Medical subject headings
- Lung Neoplasms, Sarcoma, Colorectal Neoplasms, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LonafarnibDrug
Also called SCH66336
DocetaxelDrug
Also called Taxotere
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel 36 mg/ m2 IV weekly and Lonafarnib 150 mg | Active comparator | Docetaxel 36 mg/ m^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily. Receives: Drug: Lonafarnib; Drug: Docetaxel |
| Docetaxel 30 mg/ m2and Lonafarnib 150 mg | Active comparator | Docetaxel 30 mg/ m^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily. Receives: Drug: Lonafarnib; Drug: Docetaxel |
| Docetaxel 36 mg/ m2 and Lonafarnib 100 mg | Active comparator | Docetaxel 36 mg/ m^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily Receives: Drug: Lonafarnib; Drug: Docetaxel |
| Docetaxel 30 mg/m2 and Lonafarnib 100 mg | Active comparator | Docetaxel30 mg/m^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily. Receives: Drug: Lonafarnib; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the molecular interaction
Measured: Four weeks
Secondary outcomes (1)
Determine safety and efficacy
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionMay 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Schering-Plough
- Responsible party
- Principal investigator, John Kauh, Emory University
- Investigators
- John Kauh, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288444
- Sponsor's protocol ID
- 174-2004
- Other IDs
- EU841-03
- Status last verified
- Dec 2012
- First submitted
- 6 Feb 2006
- Last updated
- 18 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Interaction of Docetaxel and Lonafarnib in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00288444
- Acronym / sponsor ID
- 174-2004
- Keywords
- Advanced malignancies.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Schering-Plough
- Study start
- Jan 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the molecular interaction in tumor samples between docetaxel and lonafarnib.
Detailed description
- To determine the safety and toxicity of intravenous docetaxel, administered on a weekly schedule (3 weeks out of 4), in combination with oral lonafarnib, administered on a daily schedule, in patients with locally advanced and metastatic solid tumor malignancies which are refractory to the standard of care.
- To determine the pharmacokinetic interaction between docetaxel and lonafarnib.
- To determine the molecular interaction in peripheral blood mononuclear cells between docetaxel and lonafarnib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Docetaxel 36 mg/ m2 IV weekly and Lonafarnib 150 mg | Active comparator | Drug: Lonafarnib, Drug: DocetaxelDocetaxel 36 mg/ m^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily. |
| Docetaxel 30 mg/ m2and Lonafarnib 150 mg | Active comparator | Drug: Lonafarnib, Drug: DocetaxelDocetaxel 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 comparator | Drug: Lonafarnib, Drug: DocetaxelDocetaxel 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 comparator | Drug: Lonafarnib, Drug: DocetaxelDocetaxel30 mg/m^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 3.2.1 Patient has received more than three previous chemotherapy regimens.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LonafarnibAlso: SCH66336 | Drug | Docetaxel 30 mg/ m2and Lonafarnib 150 mg, Docetaxel 30 mg/m2 and Lonafarnib 100 mg, Docetaxel 36 mg/ m2 IV weekly and Lonafarnib 150 mg, Docetaxel 36 mg/ m2 and Lonafarnib 100 mg |
| DocetaxelAlso: Taxotere | Drug | Docetaxel 30 mg/ m2and Lonafarnib 150 mg, Docetaxel 30 mg/m2 and Lonafarnib 100 mg, Docetaxel 36 mg/ m2 IV weekly and Lonafarnib 150 mg, Docetaxel 36 mg/ m2 and Lonafarnib 100 mg |
Primary outcome
Determine the molecular interaction
Time frame: Four weeks
1 secondary outcome
Determine safety and efficacy
Time frame: 4 Weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kauh, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lonafarnib and Docetaxel in people with Lung Cancer and Soft Tissue Sarcoma, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the molecular interaction (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.