Interaction of Docetaxel and Lonafarnib in Patients With Advanced Cancer

This study has been terminated.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Schering-Plough
Information provided by (Responsible Party):
John Kauh, Emory University
ClinicalTrials.gov Identifier:
NCT00288444
First received: February 6, 2006
Last updated: December 17, 2012
Last verified: December 2012
  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: Lonafarnib
Drug: Docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Defining the Interaction of Docetaxel and Lonafarnib in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Determine the molecular interaction [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine safety and efficacy [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: January 2006
Study Completion Date: March 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Lonafarnib
Other Name: SCH66336
Drug: Docetaxel
Other Name: Taxotere
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: Lonafarnib
Other Name: SCH66336
Drug: Docetaxel
Other Name: Taxotere
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: Lonafarnib
Other Name: SCH66336
Drug: Docetaxel
Other Name: Taxotere
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: Lonafarnib
Other Name: SCH66336
Drug: Docetaxel
Other Name: Taxotere

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Aventis Pharmaceuticals
Schering-Plough
Investigators
Principal Investigator: John Kauh, MD Emory University
  More Information

No publications provided

Responsible Party: John Kauh, MD, Emory University
ClinicalTrials.gov Identifier: NCT00288444     History of Changes
Other Study ID Numbers: 174-2004, EU841-03
Study First Received: February 6, 2006
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Advanced malignancies.

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Colorectal Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Sarcoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Connective and Soft Tissue
Docetaxel

ClinicalTrials.gov processed this record on August 26, 2014