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Home > "K" Clinical Trials Conditions > Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer  Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
For Condition: adenosquamous cell lung cancer,recurrent non-small cell lung cancer,squamous cell lung cancer,adenocarcinoma of the lung,large cell lung cancer,bronchoalveolar cell lung cancer
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AntoniusMiller, Study Chair, Comprehensive Cancer Center of Wake Forest University
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Additional Information:
Study ID Numbers: CDR0000068456; CLB-30004
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010218
Other Adenocarcinoma Of The Lung Studies:
1. Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
2. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
3. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
4. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
5. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other adenocarcinoma of the lung Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
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