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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| JHOC-J0428 | |||
| BMS-JHOC-J0428 | |||
| JHOC-BRAAN-21048 | |||
| MSGCC-0060 | |||
| JHOC-04112308 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with carboplatin followed by paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
OUTLINE: This is multicenter study.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| gemcitabine hydrochloride | Drug | |||
| paclitaxel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Progression-free survival | ||
| Time to treatment failure | ||
| Time to progression |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (complete response and partial response) |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small lung cancer (NSCLC) of any of the following histologic types:
Evidence of at least 1 of the following criteria:
Patients must have measurable or evaluable disease
Patients with brain metastases are eligible, provided they are either asymptomatic (no neurological symptoms or signs, no evidence of midline shift), or controlled (i.e., after surgical resection or radiotherapy/radiosurgery), and off all steroid therapy for at least two weeks with no evidence of progression by symptoms or radiologic imaging
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Prior chemotherapy is not allowed
At least three weeks since prior radiotherapy and recovered from all toxicities
At least three weeks must have elapsed from major surgery and recovered from all adverse effects of surgery
No prior colony-stimulating factors or interferon
No concurrent hormonal, biologic, or radiotherapy to measurable lesions
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| Name | Affiliation | Role |
|---|---|---|
| Julie Brahmer, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18201795 | Result | Bridges BB, Thomas L, Hausner PF, Doyle LA, Bedor M, Smith R, Brahmer J, Edelman MJ. Phase II trial of gemcitabine/carboplatin followed by paclitaxel in patients with performance status=2,3 or other significant co-morbidity (HIV infection or s/p organ transplantation) in advanced non-small cell lung cancer. Lung Cancer. 2008 Jul;61(1):61-6. doi: 10.1016/j.lungcan.2007.11.009. Epub 2008 Jan 16. |
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| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Baltimore |
| Maryland |
| 21231-2410 |
| United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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