Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
Tracking Information | |||||
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First Received Date ICMJE | November 17, 2005 | ||||
Last Updated Date | August 15, 2011 | ||||
Start Date ICMJE | April 2003 | ||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Evaluate the response rate (confirmed and unconfirmed complete and partial responses) of patients with metastatic melanoma when treated with vinorelbine and docetaxel. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Evaluate the response rate | ||||
Change History | Complete list of historical versions of study NCT00256282 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Assess the qualitative and quantitative toxicities of docetaxel and vinorelbine [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
Assess the qualitative and quantitative toxicities | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma | ||||
Official Title ICMJE | A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma | ||||
Brief Summary | Annually in the U.S. there is an estimated 40,000 new cases of malignant melanoma and 7000 deaths. This disease is becoming more common with its incidence increasing at a more rapid rate in the past decade than that of any other cancer except lung cancer in women. Metastatic disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and nitrosoureas, showing response rates greater than 10%. Complete responses are rare. Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a 20% response rate but has failed to consistently demonstrate a significant improvement in overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC. Recently, investigators, in an effort to combine the activity of biologic response modifiers with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha et al reported an overall objective response rate of 64% with a 5-day biochemotherapy regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified 5-day biochemotherapy regimen. The above regimens all have significant toxicities and modest response rates. Clearly, more effective less toxic regimens are needed. Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against melanoma. Additionally, the combination of both drugs has shown enhanced activity against melanoma. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Melanoma | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* 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 | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 60 | ||||
Estimated Completion Date | January 2012 | ||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256282 | ||||
Other Study ID Numbers ICMJE | UCI 02-23, 2002-2763 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | John P. Fruehauf, MD, PhD, University of California, Irvine | ||||
Study Sponsor ICMJE | University of California, Irvine | ||||
Collaborators ICMJE | Bayer | ||||
Investigators ICMJE |
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Information Provided By | University of California, Irvine | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |