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Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
This study is ongoing, but not recruiting participants.
Study NCT00049400   Information provided by National Cancer Institute (NCI)
First Received: November 12, 2002   Last Updated: July 23, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

November 12, 2002
July 23, 2008
October 2003
 
 
Complete list of historical versions of study NCT00049400 on ClinicalTrials.gov Archive Site
 
 
 
Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction

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

PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction.

OBJECTIVES:

  • Determine the levels of hepatic impairment at which dose modifications of ixabepilone are required in patients with advanced solid tumors or lymphomas and varying levels of liver dysfunction.
  • Determine the effect of hepatic dysfunction on the plasma pharmacokinetics of this drug in these patients.
  • Determine the toxic effects of this drug at varying levels of hepatic dysfunction in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24 for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.

Phase I
Interventional
Treatment
  • Lymphoma
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: ixabepilone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
84
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective

    • Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma
    • Any solid tumor or lymphoma tumor type eligible
    • Must have had thoracic and upper abdominal CT scan, including entire liver and adrenals, within 28 days before study entry
  • Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month

    • Prior whole brain or gamma knife radiotherapy required for known brain metastases
    • No unstable or untreated (non-irradiated) brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No active hemolysis

Hepatic

  • See Disease Characteristics
  • Patients with biliary obstruction for which a shunt has been placed are allowed if shunt is in place for at least 10 days and liver function is stable
  • Abnormal liver function (bilirubin and SGOT) allowed regardless of cause (metastases or other causes)
  • No evidence of biliary sepsis

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • No concurrent uncontrolled illness
  • No ongoing or active infection
  • No uncontrolled diarrhea
  • No peripheral neuropathy grade II or greater
  • No psychiatric illness or social situation that would preclude study compliance
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy for malignancy

Chemotherapy

  • More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy for malignancy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent oral contraceptives
  • No concurrent hormone therapy for malignancy

    • Concurrent luteinizing hormone-releasing hormone agonists allowed

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy for malignancy

Surgery

  • More than 2 weeks since prior major surgery

Other

  • Recovered from prior therapy
  • No concurrent medications that are known to be inhibitors of CYP3A4
Both
18 Years and older
No
 
United States
 
 
NCT00049400
 
SWOG-S0355, NCI-5707, NYU-0132
Southwest Oncology Group
National Cancer Institute (NCI)
Investigator: Angela Davies, MD University of California, Davis
Investigator: Chris H. Takimoto, MD, PhD, FACP Institute for Drug Development
National Cancer Institute (NCI)
July 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.