Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma
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ClinicalTrials.gov Identifier: NCT00673361 |
Recruitment Status
:
Terminated
First Posted
: May 7, 2008
Results First Posted
: April 26, 2013
Last Update Posted
: January 13, 2016
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Sponsor:
Duke University
Collaborator:
Bayer
Information provided by (Responsible Party):
Duke University
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Tracking Information | ||||
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First Submitted Date ICMJE | May 4, 2008 | |||
First Posted Date ICMJE | May 7, 2008 | |||
Results First Submitted Date | March 20, 2013 | |||
Results First Posted Date | April 26, 2013 | |||
Last Update Posted Date | January 13, 2016 | |||
Study Start Date ICMJE | March 2007 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks ] Terminated study before accrual goal, no data analysis
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Original Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks ] | |||
Change History | Complete list of historical versions of study NCT00673361 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years ] | |||
Original Secondary Outcome Measures ICMJE |
Response rate as determined by RECIST criteria [ Time Frame: post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma | |||
Official Title ICMJE | Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma | |||
Brief Summary | This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Melanoma | |||
Intervention ICMJE |
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Study Arms | Experimental: "Chemo-Switch" Regimen
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
9 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date | January 2009 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00673361 | |||
Other Study ID Numbers ICMJE | 9361 SR05-888 ( Other Identifier: Legacy Study ID ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Duke University | |||
Study Sponsor ICMJE | Duke University | |||
Collaborators ICMJE | Bayer | |||
Investigators ICMJE |
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PRS Account | Duke University | |||
Verification Date | December 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |