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Sponsors and Collaborators: |
University Health Network, Toronto Hoffmann-La Roche |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00603915 |
Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles; Gemcitabine will be given on day 1 and day 8 every 21 days for 6 cycles. Those patients that do not progress on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease progression. A cycle of erlotinib will be 28 days. Patients who progress on GC will be offered erlotinib as well,in order to evaluate its activity as a single-agent in the second-line setting.
Patients previously treated with GC have reported a progression-free survival (PFS) of 9 months. We would anticipate an extension of PFS to 12 months in patients treated with GC followed by maintenance erlotinib. Furthermore, we hypothesize that patients who achieved benefit from GC therapy would have further response when treated with maintenance erlotinib, such that this strategy may increase the likelihood of attaining long-term survival.
Condition | Intervention | Phase |
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Nasopharyngeal Cancer |
Drug: Gemcitabine Drug: Carboplatin/Cisplatin Drug: erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Phase II Trial of Gemcitabine and Cisplatin/Carboplatin (GC) Plus Erlotinib in Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows:
Previous Therapy:
Laboratory Requirements (must be done within 7 days prior to registration)
Hematology:
Chemistry:
(*) calculated
Exclusion Criteria:
Contact: Lillian Siu, MD | 416-946-2911 | lillian.siu@uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Sub-Investigator: Eric Chen, MD | |
Principal Investigator: Lillian Siu, MD |
Principal Investigator: | Lillian Siu, MD | University Health Network, Toronto |
Responsible Party: | Princess Margaret Hospital ( Dr. Lillian Siu ) |
Study ID Numbers: | NPC-774, NPC-774 |
Study First Received: | January 17, 2008 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00603915 |
Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
gemcitabine carboplatin cisplatin |
erlotinib tarceva nasopharyngeal |
Erlotinib Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Pharyngeal Neoplasms Carboplatin Pharyngeal Diseases Recurrence |
Nasopharyngeal Neoplasms Nasopharyngeal carcinoma Cisplatin Head and Neck Neoplasms Stomatognathic Diseases Gemcitabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Nasopharyngeal Diseases |