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Sponsors and Collaborators: |
Cancer Therapeutics Research Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077415 |
RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine as second-line therapy works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: gemcitabine hydrochloride Drug: triapine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Randomized Phase II Study Of Triapine® Alone Versus Triapine and Gemcitabine As Second-Line Treatment Of Advanced Non-Small-Cell-Lung Cancer In Patients Who Had Prior Gemcitabine With Evaluation Of The Effect Of Triapine® On Gemcitabine Pharmacokinetics and Cellular Uptake In Peripheral Mononuclear Cells |
Estimated Enrollment: | 31 |
Study Start Date: | April 2004 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to participating center.
Patients receive 3-AP (Triapine®) IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15*.
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *For course 1 only, gemcitabine is administered alone on day 1 and in combination with 3-AP (Triapine®) on days 8 and 15.
Patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 15-31 patients will be accrued for this study within 7.5-21 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed* non-small cell lung cancer (NSCLC)
One of the following cellular types:
Progressive disease after 1 prior gemcitabine-containing chemotherapy regimen for stage III or IV NSCLC and must have achieved, at least once, a partial response, complete response, or stable disease during therapy
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Australia, New South Wales | |
Sydney Cancer Centre at Royal Prince Alfred Hospital | |
Sydney, New South Wales, Australia, 2050 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital - Perth | |
Perth, Western Australia, Australia, 6009 | |
Hong Kong | |
Prince of Wales Hospital | |
Shatin, New Territories, Hong Kong | |
Korea, Republic of | |
Yonsei Cancer Center at Yonsei University Medical Center | |
Seoul, Korea, Republic of, 120-752 | |
Singapore | |
National University of Singapore | |
Singapore, Singapore, 119260 | |
Johns Hopkins Singapore International Medical Centre | |
Singapore, Singapore, 308433 | |
National Cancer Centre - Singapore | |
Singapore, Singapore, 169610 | |
Cancer Institute at National University Hospital | |
Singapore, Singapore, 119074 |
Study Chair: | Brigette Ma, MD | Prince of Wales Hospital |
Study ID Numbers: | CDR0000350313, CTRG-LUN012, NCI-6256 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077415 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer squamous cell lung cancer |
Antimetabolites Thoracic Neoplasms Anti-Infective Agents Immunologic Factors Adenocarcinoma, Bronchiolo-Alveolar Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma Radiation-Sensitizing Agents |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |