Lung Cancer
Conditions
Keywords
adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, combined type small cell lung cancer, intermediate type small cell lung cancer, large cell lung cancer, lymphocyte-like type small cell lung cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, squamous cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
Detailed description
OBJECTIVES: Primary * Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer. Secondary * Assess the response and stable disease rates and the time to disease progression among treated patients. OUTLINE: This is a dose-escalation study of topotecan. Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Interventions
DRUGtopotecan hydrochloride
DRUGvinorelbine tartrate
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed lung cancer * All histologic types eligible * Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status (PS) ≤ 2 * Karnofsky PS ≥ 60% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception * No other active invasive malignancy * No uncontrolled illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No psychiatric illness/social situation that would limit compliance with study requirements * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior radiotherapy * No prior therapy with topotecan or vinorelbine ditartrate * No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) * Recovered from agents administered \> 4 weeks earlier * No other concurrent investigational agents * No concurrent palliative radiotherapy * No other concurrent anticancer therapies or agents * No concurrent hormones or other chemotherapy except for the following: * Steroids for adrenal failure * Hormones for nondisease-related conditions (e.g., insulin for diabetes) * Intermittent dexamethasone as an antiemetic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | Cycle 1 (up to day 21) |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | while on study, at the end of each 3 week cycle |
| stable disease rate | while on study, at the end of each 3 week cycle |
| time to progression | from start of treatment to day of documented progression or death, whichever comes first, up to 36 months |
Countries
United States
Outcome results
None listed