COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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: NCT00004057
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : June 21, 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 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 or disease Intervention/treatment Phase
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Drug: L-778,123 Drug: paclitaxel Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Primary Purpose: 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
Study Start Date : December 1998
Actual Primary Completion Date : December 2000
Actual Study Completion Date : December 2000

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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): NCT00004057

Layout table for location information
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)
Layout table for investigator information
Study Chair: David R. Spriggs, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00004057    
Other Study ID Numbers: 98-116
CDR0000067254 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 13, 2004    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action