Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment … (NCT00540982) | Clinical Trial Compass
CompletedPhase 1/2
Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction
United States47 participantsStarted 1997-02-20
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 investiga…
What they're measuring
1
Area Under the Curve
Timeframe: 2 months post treatment
2
Number of Participants With Grade 3 and 4 Toxicities