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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00049400
Other study ID # S0355
Secondary ID U01CA076642P30CA
Status Completed
Phase Phase 1
First received November 12, 2002
Last updated April 1, 2015
Start date October 2003
Est. completion date December 2007

Study information

Verified date April 2015
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date December 2007
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
BMS-247550
BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle

Locations

Country Name City State
United States St. Joseph Hospital Community Cancer Center Bellingham Washington
United States Olympic Hematology and Oncology Bremerton Washington
United States Case Comprehensive Cancer Center Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States City of Hope Comprehensive Cancer Center Duarte California
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Community Oncology Group at Cleveland Clinic Cancer Center Independence Ohio
United States Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas
United States Wilford Hall Medical Center Lackland AFB Texas
United States USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
United States Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois
United States Skagit Valley Hospital Cancer Care Center Mt. Vernon Washington
United States University of California Davis Cancer Center Sacramento California
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington
United States University Cancer Center at University of Washington Medical Center Seattle Washington
United States North Puget Oncology at United General Hospital Sedro-Wooley Washington
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Wenatchee Valley Medical Center Wenatchee Washington
United States Cleveland Clinic - Wooster Wooster Ohio

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Takimoto CH, Liu PY, Lenz H, et al.: A phase I pharmacokinetic (PK) study of the epothilone B analogue, ixabepilone (BMS-247550) in patients (pts) with advanced malignancies and varying degrees of hepatic impairment. A SWOG Early Therapeutics Committee an

Outcome

Type Measure Description Time frame Safety issue
Primary dose defining Treatment delays >2 weeks constitute a DLT Yes
Secondary Progression 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. 30 days after going off study No
Secondary Symptomatic deterioration Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. 30 days after going off study Yes
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