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Phase II Study of Imatinib Mesylate and Gemcitabine for Recurrent/Metastatic Non-small Cell Lung Cancer (NSCLC)
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.
Details
| Lead sponsor | Rutgers, The State University of New Jersey |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 17 |
| Start date | 2006-04 |
| Completion | 2008-10 |
Conditions
- Lung Cancer
Interventions
- gemcitabine hydrochloride
- imatinib mesylate
Primary outcomes
- Percentage of Patients Who Meet Critieria for Response — 2 years
Response is considered Partial Response or Complete Response as per RECIST criteria. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Countries
United States