Back to resultsKarenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
karenitecin
Sponsored by
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
Arm Type
Experimental
Arm Label
karenitecin
Arm Description
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.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00010218
First Posted
February 2, 2001
Last Updated
July 15, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00010218
Brief Title
Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Official Title
Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
karenitecin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
karenitecin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonius A. Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago (Westside Hospital)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Hematology Oncology Associates of the Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Veterans Affairs Medical Center - Columbia (Truman Memorial)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13217
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Green Mountain Oncology Group
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Veterans Affairs Medical Center - White River Junction
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15893009
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Learn more about this trial
Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
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