Lung Cancer
Conditions
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have progressive locally advanced or metastatic non-small cell lung cancer.
Detailed description
OBJECTIVES: * Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival time and 12-month survival rate of patients treated with this drug. * Determine the quantitative and qualitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1. Patients are followed for survival every 3 months after discontinuing study treatment. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.
Interventions
DRUGsoblidotin
Sponsors
Daiichi Sankyo
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Locally advanced or metastatic disease * Demonstrates tumor progression * Must have received 1 prior chemotherapy regimen * Prior chemotherapy must have included a platinum agent * Measurable disease * At least 1 measurable lesion outside the field of any prior radiotherapy * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine no greater than 1.5 times ULN Cardiac * Ejection fraction at least 40% by MUGA Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychiatric disorder that would preclude giving informed consent or following study instruction * No grade 2 or greater neurotoxicity * No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years prior to study entry * No other concurrent severe or uncontrolled underlying medical disease that would compromise patient safety and study outcome * No concurrent serious infection PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic therapy Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No concurrent anticancer radiotherapy * Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective Surgery * At least 4 weeks since prior major surgery and recovered Other * At least 4 weeks since prior myelosuppressive therapy * More than 28 days since prior investigational drugs * No other concurrent investigational drugs * No other concurrent anticancer cytotoxic therapy
Countries
United States
Outcome results
None listed