NCT00049400
S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
PHASE1
COMPLETED
NCT00049400
INTERVENTIONAL
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.
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
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
- TREATMENT
-
- Type: DRUG
- Name: BMS-247550
- Description: BMS-247550 as a 3-hour infusion on Day 1 of a three-week cycle
- Arm Group Labels: treatment
- SWOG Cancer Research Network