Interaction of Docetaxel and Lonafarnib in Patients With Advanced Cancer

December 17, 2012 updated by: John Kauh, Emory University

Defining the Interaction of Docetaxel and Lonafarnib in Patients With Advanced Malignancies

To determine the molecular interaction in tumor samples between docetaxel and lonafarnib.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  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

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Winship Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:.1.1 Patient must have a pathologically-confirmed locally advanced or metastatic solid tumor malignancy demonstrated to be refractory to the standard of care, with tumors accessible by needle or surgical biopsy.

3.1.2 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.

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:

3.2.1 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.

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Docetaxel
Other Names:
  • Taxotere
Drug: Lonafarnib
Other Names:
  • SCH66336
Active Comparator: Docetaxel 30 mg/ m2and Lonafarnib 150 mg
Docetaxel 30 mg/ m^2 Intravenously weekly and Lonafarnib 150 mg by mouth twice a day daily.
Drug: Docetaxel
Other Names:
  • Taxotere
Drug: Lonafarnib
Other Names:
  • SCH66336
Active Comparator: 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
Drug: Docetaxel
Other Names:
  • Taxotere
Drug: Lonafarnib
Other Names:
  • SCH66336
Active Comparator: Docetaxel 30 mg/m2 and Lonafarnib 100 mg
Docetaxel30 mg/m^2 Intravenously weekly and Lonafarnib 100 mg by mouth twice a day daily.
Drug: Docetaxel
Other Names:
  • Taxotere
Drug: Lonafarnib
Other Names:
  • SCH66336

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the molecular interaction
Time Frame: Four weeks
Four weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine safety and efficacy
Time Frame: 4 Weeks
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Schering-Plough
Aventis Pharmaceuticals

Investigators

  • Principal Investigator: John Kauh, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 174-2004
  • EU841-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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