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Interaction of Docetaxel and Lonafarnib in Patients With Advanced Cancer
This study is currently recruiting participants.
Verified by Emory University, February 2006
Sponsors and Collaborators: Emory University
Aventis Pharmaceuticals
Schering-Plough
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00288444
  Purpose

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


Condition Intervention Phase
Lung Cancer
Soft Tissue Sarcoma
Colorectal Carcinoma
Breast Cancer
Prostate Cancer
Drug: SCH 66336
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Lung Cancer Prostate Cancer Soft Tissue Sarcoma
Drug Information available for: Docetaxel Lonafarnib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Defining the Interaction of Docetaxel and Lonafarnib in Patients With Advanced Malignancies

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Determine the molecular interaction

Secondary Outcome Measures:
  • Determine safety and efficacy
  • Determine pharmacokinetic interaction.

Estimated Enrollment: 36
Study Start Date: January 2006
Estimated Study Completion Date: December 2008
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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288444

Locations
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30308
Contact: Michael P Fanucchi, MD     404-686-3496     michael.fanucchi@emoryhealthcare.org    
Contact: Fadlo Khuri, MD     404-778-4250     fadlo.khuri@emoryhealthcare.org    
Sponsors and Collaborators
Emory University
Aventis Pharmaceuticals
Schering-Plough
Investigators
Principal Investigator: Michael P Fanucchi, MD Emory University
  More Information

Study ID Numbers: 174-2004, EU841-03
Study First Received: February 6, 2006
Last Updated: February 6, 2006
ClinicalTrials.gov Identifier: NCT00288444  
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Advanced malignancies.

Study placed in the following topic categories:
Thoracic Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Gastrointestinal Diseases
Malignant mesenchymal tumor
Colonic Diseases
Urogenital Neoplasms
Rectal Diseases
Soft tissue sarcomas
Docetaxel
Neoplasms, Connective and Soft Tissue
Respiratory Tract Diseases
Lung Neoplasms
Breast Diseases
Digestive System Neoplasms
Skin Diseases
Breast Neoplasms
Intestinal Diseases
Genital Diseases, Male
Intestinal Neoplasms
Carcinoma
Digestive System Diseases
Lung Diseases
Sarcoma
Gastrointestinal Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009