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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00010218 |
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 | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: karenitecin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial Of Karenitecin (IND 57250) In Patients With Relapsed or Refractory Non-Small Cell Lung Cancer |
Study Start Date: | April 2001 |
OBJECTIVES:
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed relapsed or refractory non-small cell lung carcinoma (NSCLC)
At least 1 unidimensionally measurable lesion
Lesions that are not considered measurable include the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Antonius A. Miller, MD | Wake Forest University |
Study ID Numbers: | CDR0000068456, CLB-30004 |
Study First Received: | February 2, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00010218 |
Health Authority: | United States: Federal Government |
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 |
Thoracic Neoplasms Non-small cell lung cancer Adenocarcinoma of lung Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms |
Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |