Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic Head and Neck Cancer
Recruitment status was Active, not recruiting
Tracking Information | |||||
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First Received Date ICMJE | November 17, 2005 | ||||
Last Updated Date | May 6, 2010 | ||||
Start Date ICMJE | April 2005 | ||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To assess the overall response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
To assess the overall response rate | ||||
Change History | Complete list of historical versions of study NCT00256295 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
To assess the frequency and severity of toxicities [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
To assess the frequency and severity of toxicities | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic Head and Neck Cancer | ||||
Official Title ICMJE | A Phase II Study of Weekly Oxaliplatin and Gemcitabine Combination Chemotherapy for Recurrent or Metastatic Head and Neck Cancer | ||||
Brief Summary | The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8 oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was 16% with no incidence of febrile neutropenia. Toxicity is a crucial consideration when designing regimens intended for palliation. Toxicities associated with cisplatin can make it difficult to use in patients with HNC, many of whom are elderly and have comorbidities. In addition, many patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant therapy, or as part of their primary chemoradiation treatment. When these patients recur, it is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely to be better tolerated than cisplatin containing regimens, especially with regards to neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen. |
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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 | Cancer of the Head and Neck | ||||
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 | 15 | ||||
Estimated Completion Date | December 2010 | ||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Patients must not have prior therapy with oxaliplatin or gemcitabine
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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 | NCT00256295 | ||||
Other Study ID Numbers ICMJE | UCI 04-08 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Sai-Hong Ignatius Ou, MD, University of California, Irvine Medical Center | ||||
Study Sponsor ICMJE | University of California, Irvine | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of California, Irvine | ||||
Verification Date | May 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |