search
Back to results

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

Primary Purpose

Head and Neck Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
L-778,123
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 24, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003430
Brief Title
L-778,123 in Treating Patients With Recurrent or Refractory Solid Tumors
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
April 2000 (Actual)
Study Completion Date
April 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-778,123

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Spriggs, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs