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Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00010218
Collaborator
National Cancer Institute (NCI) (NIH)
55
Enrollment
44
Locations
1
Arm
57
Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-small Cell Lung Cancer
Study Start Date :
Apr 1, 2001
Actual Primary Completion Date :
Apr 1, 2003
Actual Study Completion Date :
Jan 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: karenitecin

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Alliance for Clinical Trials in Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Antonius A. Miller, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alliance for Clinical Trials in Oncology
    ClinicalTrials.gov Identifier:
    NCT00010218
    Other Study ID Numbers:
    • CALGB-30004
    • U10CA031946
    • CLB-30004
    • CDR0000068456
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 19, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Alliance for Clinical Trials in Oncology
    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
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 19, 2016