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L-778,123 in Treating Patients With Recurrent or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003430
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : June 25, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of L-778,123 in treating patients with recurrent or refractory solid tumors.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: L-778,123 Phase 1

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of L-778,123 in patients with recurrent or refractory solid tumors. II. Evaluate the safety and tolerability of L-778,123 including qualitative, quantitative, and dose limiting toxicity in these patients. III. Assess the pharmacokinetic profile of this regimen in these patients. IV. Evaluate the radiologic or tumor marker responses to treatment in these patients. V. Evaluate the relationship between ras mutations and response to treatment in these patients. VI. Determine the relationship between plasma drug levels and farnesylation assay results.

OUTLINE: This is a dose escalation study. Patients receive continuous infusions of L-778,123 over 7 days every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxic effects. All patients are observed for at least 1 week after the 7 day infusion of L-778,123 prior to subsequent dose escalation. Cohorts of 3-6 patients receive escalating doses of L-778,123 until the maximum tolerated dose (MTD) is reached. MTD is defined as the dose at which no more than 2 of 6 patients experiences dose limiting toxicities. Patients are followed until death.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study Evaluating the Safety, Tolerability and Maximally Tolerated Dose of 7-Day Continuous Infusions of L-778,123 in Patients With Recurrent of Refractory Solid Malignancies
Study Start Date : April 1998
Actual Primary Completion Date : April 2000
Actual Study Completion Date : April 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory solid tumors including, but not limited to: Pancreatic cancer Bladder cancer Colon cancer Head and neck cancer Lung cancer Measurable disease or a measurable tumor marker (not based solely on cytopathological data) No primary or active metastatic CNS disease (assessed by edema or 2 radiologic imaging techniques at least 4 weeks apart)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 PT or PTT no greater than 1.2 times upper limit of normal (ULN) Hepatic: Bilirubin no greater than 1.5 time ULN ALT or AST no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No grade 3 cardiac dysrhythmias No atrial fibrillation No prior myocardial infarction No history of unstable angina No history of congestive heart failure LVEF greater than 50% in patients with prior cumulative anthracycline dose less than 450 mg/m2 of doxorubicin Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception for at least 2 weeks before, throughout, and at least 2 weeks after the study Permanent central venous catheter in place No history of illicit drug or alcohol abuse within the past 5 years No emotional or psychiatric disorders No known significant drug allergies or serious adverse experiences with marketed or investigational drugs No allergy to latex Normal serum electrolytes No other serious medical disorders No active infections No history of significant retinal disorder or disease No history of seizure disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunologic therapy No concurrent immunologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since prior mitomycin or nitrosoureas No prior high dose chemotherapy with stem cell rescue No other concurrent chemotherapy No prior anthracycline dose exceeding the equivalent of greater than 45O mg/m2 of doxorubicin Endocrine therapy: At least 4 weeks since prior endocrine therapy (including steroids) No concurrent endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiation to greater than 25% of total bone marrow No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery No concurrent surgery Other: At least 30 days since prior investigational agents No concurrent medications with dysrhythmic potential including, but not limited to: terfenadine, astemizole, cisapride, diphenhydramine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, tricyclic antidepressants, haloperidol, risperidone, and indapamine No concurrent rifampin, phenobarbital, phenytoin, or other inducers of CYP3A No concurrent triazolam, alprazolam, midazolam, or other CYP3A metabolized benzodiazepines No concurrent HMG-CoA reductase inhibitors (except fluvastatin) No concurrent anticoagulant therapy (low dose warfarin therapy to maintain catheter patency allowed)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003430

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: David R. Spriggs, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00003430    
Other Study ID Numbers: 98-033
CDR0000066456 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 13, 2004    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent nasopharyngeal cancer
unspecified adult solid tumor, protocol specific
recurrent lip and oral cavity cancer
recurrent hypopharyngeal cancer
recurrent laryngeal cancer
recurrent paranasal sinus and nasal cavity cancer
recurrent oropharyngeal cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site