Lung Cancer
Conditions
Keywords
recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer
Detailed description
OBJECTIVES: * Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy. * Determine the effect of prior response to chemotherapy on response to this drug in these patients. * Determine survival and failure-free survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients. OUTLINE: Patients are stratified according to response to prior chemotherapy (relapsed vs refractory). Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A minimum of 45 patients (25 for stratum I and 20 for stratum II) will be accrued for this study within 12 months.
Interventions
DRUGkarenitecin
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed relapsed or refractory non-small cell lung carcinoma (NSCLC) * Squamous cell carcinoma * Basaloid carcinoma * Adenocarcinoma * Bronchoalveolar carcinoma * Adenosquamous cell carcinoma * Large cell carcinoma * Large cell neuroendocrine carcinoma * Giant cell carcinoma * Sarcomatoid carcinoma * Non-small cell carcinoma not otherwise specified * Histologic or cytologic documentation of recurrence required if disease previously completely resected * Must have had only 1 prior chemotherapy regimen, including adjuvant or neoadjuvant therapy for NSCLC * At least 1 unidimensionally measurable lesion * At least 20 mm with conventional techniques OR * At least 10 mm with spiral CT scan * Lesions that are not considered measurable include the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Abdominal masses not confirmed and followed by imaging techniques * Cystic lesions * Tumor lesions in a previously irradiated area * Controlled CNS metastases allowed if patient is neurologically stable and off steroids PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than upper limit of normal Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin) * No prior irinotecan or other camptothecin drug * No other concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent hormonal therapy except for non-cancer-related conditions (e.g., insulin for diabetes) * No concurrent steroids except for adrenal failure Radiotherapy: * See Disease Characteristics * Prior radiotherapy for symptomatic lesions or those that might produce disability (e.g., painful bone metastases) allowed if other measurable disease present * At least 4 weeks since prior radiotherapy * No concurrent palliative radiotherapy Surgery: * See Disease Characteristics
Countries
United States
Outcome results
None listed