Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Paclitaxel Plus L-778,123 in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphomas
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004057
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel and L-778,123 in treating patients who have recurrent or refractory solid tumors or lymphomas.


Condition Intervention Phase
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: L-778,123
Drug: paclitaxel
Phase I

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Paclitaxel L 778,123
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I and Pharmacokinetic Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of Combination Therapy With Paclitaxel and L-778,123 in Patients With Recurrent or Refractory Solid Malignancies

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: December 1998
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of L-778,123 when combined with paclitaxel in patients with recurrent or refractory solid tumors or lymphomas. II. Evaluate the safety, tolerability, and dose limiting toxicity of this regimen in these patients. III. Assess steady state plasma concentrations of various doses of L-778,123 combined with paclitaxel in these patients. IV. Evaluate radiologic or tumor marker responses to this regimen in these patients. V. Evaluate the relationship between ras mutations and response to this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of L-778,123. Patients receive paclitaxel IV over 3 hours followed within 24 hours by L-778,123 IV over 7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive 2 courses after documentation of response. Cohorts of 1-3 patients receive escalating doses of L-778,123 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at about 2 weeks.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven solid tumor or lymphoma that is recurrent or refractory to standard first line therapy Measurable or evaluable disease No active or inactive primary CNS malignancy No untreated active metastatic CNS malignancy No leukemia or plasma cell dyscrasias

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times normal ALT or AST no greater than 2.5 times normal Alkaline phosphatase no greater than 4 times normal (no greater than 2 times normal if an increase of greater than 25% over past 2 weeks) PT, INR, or aPTT no greater than 1.2 times normal Renal: Creatinine no greater than 1.5 times normal Electrolytes within 10% of normal range Cardiovascular: No prior grade 3 or 4 cardiac arrhythmias except atrial fibrillation No QTc interval of 440 milliseconds or greater on electrocardiogram No other QTc abnormalities No myocardial infarction, unstable angina, or congestive heart failure within the past 12 months Psychiatric: No mental or legal incapacitation No concurrent significant emotional problems No prior psychiatric disorder Neurologic: No grade 2 or higher peripheral neuropathy No prior seizure disorder Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double barrier contraception or practice abstinence for at least 14 days before, during, and for at least 14 days after therapy No allergy to latex, Cremophor (found in formulations of cyclosporine or vitamin K), or paclitaxel HIV negative No HIV related malignancy No active infection No prior significant retinal disorder or disease At least 5 years since prior drug or alcohol abuse

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent immunotherapy No concurrent colony stimulating factors or epoetin alfa Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) At least 4 weeks since prior paclitaxel and recovered No prior high dose chemotherapy with stem cell rescue No other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy (except chronic LHRH agonist replacement therapy administered for at least 3 months) No concurrent endocrine therapy except prophylactic steroids during first course of chemotherapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery No concurrent surgery Permanent indwelling central venous catheter required Other: At least 4 weeks since prior investigational agents (including FDA approved drugs for non-FDA approved indication) No concurrent medications that prolong QTc interval (e.g., terfenadine, astemizole, cisapride, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, tricyclic antidepressants, haloperidol, risperidone, indapamide, and dolasetron mesylate) No concurrent potent inducers of CYP3A (e.g., rifampin, phenobarbital, phenytoin, carbamazepine, troglitazone, and rifabutin) No concurrent benzodiazepines that are metabolized by CYP3A (e.g., triazolam, alprazolam, and midazolam) No concurrent HMG-CoA reductase inhibitors that are metabolized by CYP3A No other prophylactic medications during first course of chemotherapy except antihistamines and H2 antagonists (for paclitaxel) No more than 6 cups of coffee or the equivalent for other caffeinated beverages per day At least 24 hours since prior alcohol consumption No alcohol consumption while confined to the clinical research unit No more than 24 ounces of beer, 8 ounces of wine, or 3 ounces of whiskey or other equivalent hard liquor per day while not confined to the clinical research unit No concurrent illicit drugs No concurrent prochlorperazine

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004057

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David R. Spriggs, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000067254, MSKCC-98116, MERCK-003-04, NCI-G99-1572
Study First Received: December 10, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004057  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
unspecified adult solid tumor, protocol specific
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent mantle cell lymphoma
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Hodgkin's disease
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Leukemia-Lymphoma, Adult T-Cell
Immunoblastic Lymphadenopathy
Lymphoblastic lymphoma
Mantle cell lymphoma
Recurrence
Lymphatic Diseases
Paclitaxel
Burkitt Lymphoma
B-cell lymphomas

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009