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

Phase 1
Not Enrolling
Lung Cancer, Soft Tissue Sarcoma, Colorectal Carcinoma, Breast Cancer, Prostate Cancer

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Trial Information

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

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

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


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.


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the molecular interaction

Outcome Time Frame:

Four weeks

Safety Issue:


Principal Investigator

John Kauh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

March 2009

Related Keywords:

  • Lung Cancer
  • Soft Tissue Sarcoma
  • Colorectal Carcinoma
  • Breast Cancer
  • Prostate Cancer
  • Advanced malignancies.
  • Breast Neoplasms
  • Carcinoma
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms
  • Sarcoma



Emory University Winship Cancer Institute Atlanta, Georgia  30322