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

Condition	Treatment or Intervention	Phase
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	Drug: karenitecin  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

California
      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143-0128,  United States
      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Lombardi Cancer Center, Washington,  District of Columbia,  20007,  United States
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States
Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States
Iowa
      Hematology Oncology Associates of the Quad Cities, Bettendorf,  Iowa,  52722,  United States
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
Maryland
      Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      University of Massachusetts Memorial Medical Center - University Campus, Worcester,  Massachusetts,  01655,  United States
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States
Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States
Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756-0002,  United States
New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States
      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States
      Weill Medical College of Cornell University, New York,  New York,  10021,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States
Rhode Island
      Lifespan: The Miriam Hospital, Providence,  Rhode Island,  02906,  United States
Vermont
      Green Mountain Oncology Group, Bennington,  Vermont,  05201,  United States
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
      Veterans Affairs Medical Center - White River Junction, White River Junction,  Vermont,  05009,  United States
Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States

Study chairs or principal investigators

Antonius Miller, MD,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000068456; CLB-30004
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010218
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08