Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small… (NCT00408460) | Clinical Trial Compass
CompletedPhase 2
Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
United States34 participantsStarted 2006-02
Plain-language summary
This phase II trial is studying how well giving imatinib mesylate together with paclitaxel works in treating older patients with stage IIIB or stage IV non-small cell lung cancer. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with paclitaxel may kill more tumor cells
Who can participate
Age range70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic or cytologic diagnosis of non-small cell lung cancer
* At least one site of measurable disease, as defined by the modified RECIST criteria
* Stage IIIB with pleural effusion or Stage IV disease; includes patients who received surgery alone for early stage disease, now in relapse with advanced disease; staging is according to the American Joint Committee on Cancer classification scheme, 6th edition
* Total bilirubin \< 1.25 x upper limit of normal (ULN)
* Baseline absolute neutrophil count \>= 1500/uL
* Baseline platelet count \>= 100,000/uL
* ECOG Performance Status 0, 1 or 2 at the time of informed consent
* Written, voluntary consent
* Patients with reproductive potential must use an acceptable contraceptive method, such methods include: 1) Male hormonal contraception; 2) Partner without reproductive potential, including post-menopausal status or history of tubal ligation; 3) Partner with intrauterine device (IUD) or contraceptive vaginal ring; 4) Partner takes oral contraceptive pill, wears contraceptive patch, or has contraceptive implant; 5) Routine use of barrier method, such as condoms or diaphragm, during sexual intercourse
* AST and ALT =\< 2.5 x ULN
* Creatinine =\< 1.5 x ULN
Exclusion Criteria:
* Uncontrolled brain metastasis; patients with known brain metastasis must have completed treatment with surgery, radiation or both; in addition, they must be off corticosteroids
* Symptomatic neuropathy (Grade 2 or higher)
* Prior chemoth…
What they're measuring
1
Overall Response Rate (Complete and Partial Responses) as Assessed by RECIST Criteria