Phase 2
Completed N=47
Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction
Lung Cancer · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00540982 ↗
Enrolled (actual)
47
Serious AEs
14.9%
Results posted
Mar 2019
Primary outcomePrimary: Area Under the Curve — 271; 537; 341; 324 ng/ml x hr
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve |
271; 537; 341; 324 | — |
| PRIMARY Number of Participants With Grade 3 and 4 Toxicities |
1; 0; 2; 0; 1; 3 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00540982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.