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Status:

TERMINATED

Interaction of Docetaxel and Lonafarnib in Patients With Advanced Cancer

Lead Sponsor:

Emory University

Collaborating Sponsors:

Aventis Pharmaceuticals

Schering-Plough

Conditions:

Lung Cancer

Soft Tissue Sarcoma

Eligibility:

All Genders

Phase:

PHASE1

Brief Summary

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

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 patien...

Eligibility Criteria

Inclusion

  • .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.
  • 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.
  • 1.3 Patient must have an ECOG performance status of 2 or less.
  • 1.4 Patient must have a life-expectancy of at least 12 weeks.
  • 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.
  • 1.6 Patient must have adequate liver function: total bilirubin level ≤ 2.0 mg/dL and ≤ ULN, albumin ≥ 2.5 g/dL.
  • 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.
  • 1.8 Patient must have received no more than three previous chemotherapy regimens (prior chemotherapy may or may not have contained a taxane).
  • 1.9 Patient must meet the specified informed consent requirement.
  • 1.10 Patient must be of age ≥ 18 years.
  • 1.11 Women of childbearing age must have a negative pregnancy test.
  • 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.
  • 1.13 Patient must have ≤ Grade 1 neurotoxicity from previous anticancer treatment or from any cause.
  • 1.14 Patient must have adequate coagulation function: INR and PTT ≤ 1.5 x ULN.
  • 1.15 Patient must have discontinued all prior chemotherapy and radiotherapy at least 4 weeks prior to registration.
  • 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

  • 2.1 Patient has received more than three previous chemotherapy regimens.
  • 2.2 Patient is pregnant or breast feeding.
  • 2.3 Patient has signs of symptoms of acute infection requiring systemic therapy.
  • 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.
  • 2.5 Patient's life expectancy is less than 12 weeks.
  • 2.6 Patient has \> Grade 1 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause.
  • 2.7 Patient requires total parenteral nutrition with lipids.
  • 2.8 Inability to swallow the lonafarnib BID.
  • 2.9 Patient has a history of uncontrolled heart disease (including clinically significant coronary artery disease, congestive heart failure and symptomatic or uncontrolled arrythmias).
  • 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.
  • 2.11 Use of chronic steroids or anticonvulsants.
  • \-

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT00288444

Start Date

January 1 2006

End Date

March 1 2009

Last Update

December 18 2012

Active Locations (1)

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Emory University Winship Cancer Institute

Atlanta, Georgia, United States, 30308