|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors | ||||
| Official Title † | Phase I Study of Sorafenib, Pemetrexed, and Cisplatin for the Treatment of Advanced Solid Tumors. | ||||
| Brief Summary | RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with pemetrexed and cisplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with pemetrexed and cisplatin in treating patients with advanced solid tumors. |
||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a dose-escalation study of sorafenib tosylate. Patients receive oral sorafenib tosylate once daily on days 1-21 and cisplatin IV over 1-2 hours and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days, every 8 weeks until disease progression, and then every 3 months for up to 6 months. |
||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | Maximum tolerated dose of sorafenib tosylate [ Designated as safety issue: Yes ] Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ] Disease response as assessed by RECIST criteria [ Designated as safety issue: No ] |
||||
| Secondary Outcome Measure † | |||||
| Condition † | Breast Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Malignant Mesothelioma Pancreatic Cancer Prostate Cancer Sarcoma |
||||
| Intervention † | Drug: cisplatin Drug: pemetrexed disodium Drug: sorafenib tosylate |
||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 12 | ||||
| Start Date † | May 2008 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00703638 | ||||
| Organization ID | CDR0000597879 | ||||
| Secondary IDs †† | UMN-2007LS086, 0712M22703, BAYER-UMN-2007LS086 | ||||
| Study Sponsor † | Masonic Cancer Center, University of Minnesota | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | June 20, 2008 | ||||
| Last Updated Date | September 22, 2008 | ||||