Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
NCT ID: NCT00010218
Last Updated: 2016-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2001-04-30
2006-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
karenitecin
Interventions
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karenitecin
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Antonius A. Miller, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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Miller AA, Herndon JE 2nd, Gu L, Green MR; Cancer and Leukemia Group B. Phase II trial of karenitecin in patients with relapsed or refractory non-small cell lung cancer (CALGB 30004). Lung Cancer. 2005 Jun;48(3):399-407. doi: 10.1016/j.lungcan.2004.11.019. Epub 2005 Jan 23.
Herndon JE, Miller AA, Zhang C, et al.: Phase II trial of karenitecin in patients with refractory non-small cell lung cancer (NSCLC): CALGB 30004 . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2706, 673, 2003.
Other Identifiers
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CLB-30004
Identifier Type: -
Identifier Source: secondary_id
CDR0000068456
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-30004
Identifier Type: -
Identifier Source: org_study_id
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