Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction

• Status: Completed
• Trial end date: 2010-05-20
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This pilot trial is studying the side effects and best dose of vinorelbine in treating patients with advanced solid tumors that have not responded to treatment and liver dysfunction.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lidocaine; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced solid tumor

• Any histology allowed

• Refractory to standard therapy OR no standard therapy exists

• Previously untreated non-small cell lung cancer allowed, provided abnormal liver function is present, defined as moderate (group 3) or severe (group 4)

• Measurable disease not required

• Present measurable disease requires baseline measurements within 4 weeks of study entry

• Patients with acute hepatitis from viral or drug etiologies should recover to a stable baseline prior to study therapy

• History of brain metastasis allowed, provided the following criteria are met:

• Metastasis has been controlled by radiotherapy or surgery

• Patient is not currently on corticosteroids

• Neurologic status is stable

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Life expectancy ≥ 2 months

• ANC = 1,500/mm³

• Platelet count = 100,000/mm³

• Hemoglobin = 10 g/dL (transfusion to this level allowed)

• Creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/ min

• Patients with EKG evidence of first- or second-degree AV block or left or right bundle branch block are ineligible for the lidocaine bolus, but may otherwise be treated on this protocol

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No concurrent illness (e.g., cardiovascular, pulmonary, or central nervous system) that is poorly controlled or of such severity that the investigator deems unwise to enter the patient on protocol

• Must have ability to comply with study treatment and required tests

• Obstructive jaundice requires a drainage procedure prior to study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea therapy)

• No prior radiotherapy to > 30% of the bone marrow or more than standard adjuvant pelvic radiotherapy for rectal cancer