Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Rebecca and John Moores UCSD Cancer Center
- Veterans Affairs Medical Center - San Francisco
- UCSF Comprehensive Cancer Center
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center
- Walter Reed Army Medical Center
- CCOP - Mount Sinai Medical Center
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- CCOP - Northern Indiana CR Consortium
- Hematology Oncology Associates of the Quad Cities
- Holden Comprehensive Cancer Center
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Dana-Farber Cancer Institute
- University of Massachusetts Memorial Medical Center - University Campus
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center - Columbia
- Barnes-Jewish Hospital
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- Weill Medical College of Cornell University
- Mount Sinai Medical Center, NY
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Lineberger Comprehensive Cancer Center, UNC
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital - Ohio State University
- Lifespan: The Miriam Hospital
- Green Mountain Oncology Group
- Vermont Cancer Center
- Veterans Affairs Medical Center - White River Junction
- MBCCOP - Massey Cancer Center
Arms of the Study
Arm 1
Experimental
karenitecin
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.