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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00323362 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: gemcitabine hydrochloride Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 53 |
Study Start Date: | March 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, nonrandomized, uncontrolled, open-label study.
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell cancer
Received at least 1 prior chemotherapy regimen and meets the following criteria:
Patients who received prior chemotherapy in the adjuvant setting are eligible when 1 of the following criteria is met:
Measurable disease
No known or untreated brain metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
No uncontrolled illness that would preclude study compliance, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, New Jersey | |
Cancer Institute of New Jersey at Hamilton | |
Hamilton, New Jersey, United States, 08690 | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 | |
Saint Peter's University Hospital | |
New Brunswick, New Jersey, United States, 08903 |
Principal Investigator: | Mika Sovak, MD, PhD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000539557, CINJ-030503, CINJ-0220060014, CINJ-NJ1505 |
Study First Received: | March 7, 2006 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00323362 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IV non-small cell lung cancer |
Imatinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Gemcitabine Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |