S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: 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 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: 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