Overview
S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
Status:
Completed
Completed
Trial end date:
2007-12-01
2007-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Southwest Oncology GroupCollaborator:
National Cancer Institute (NCI)Treatments:
Epothilones
Criteria
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