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Sponsors and Collaborators: |
University Health Network, Toronto Abraxis BioScience Inc. |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00731380 |
The purpose of this study is to determine the highest dose of a ABI-007 that can be given with cisplatin and 5-fluorouracil without causing intolerable side effects in patients with advanced head and neck cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: ABI-007 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Phase I Trial of ABI-007 (Abraxane) Plus Cisplatin Plus 5-Fluorouracil (APF) as Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Patients With Locally Advanced Squamous Cell Cancers of the Head and Neck (HNSCC) |
Estimated Enrollment: | 27 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Squamous cell carcinoma of the head and neck (HNSCC) is the 9th most common malignancy diagnosed in Canadians. In the year 2007, there was an estimated 4,350 new cases diagnosed in Canada, with approximately 1,600 deaths attributable to HNSCC[Canadian Cancer Statistics 2007]. In the United States there is an annual incidence of approximately 40,000 newly diagnosed cases of head and neck cancer [US Cancer Statistics 2006]. Primary treatment for newly diagnosed localized (stage I-II) HNSCC is surgery and/or radiotherapy. The majority of patients (70%) however present with locally advanced HNSCC (Stage III or IV). Treatment of locally advanced HNSCC generally consists of either concurrent chemotherapy and radiation or surgical resection followed by adjuvant radiation or adjuvant concurrent chemotherapy and radiation. Unfortunately despite aggressive treatment with combined modality therapies approximately 40-50% of cases recur, with the majority recurring at the primary site and/or regional nodes. Except for a small minority of patients in whom salvage surgery or radiotherapy can be delivered, the prognosis for the majority of these patients is poor and further treatment is generally considered palliative.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate hematological function:
Must have adequate renal and hepatic function:
Exclusion Criteria:
Contact: Lillian Siu, MD | 416.946.2911 | lillian.siu@uhn.on.ca |
Contact: John Waldron, MD | 416.946.4501 ext 6522 | john.waldron@rmp.uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 3M9 | |
Contact: Soo Chin, RN soo.chin@uhn.on.ca | |
Principal Investigator: Lillian Siu, MD | |
Principal Investigator: John Waldron, MD |
Principal Investigator: | Lillian Siu, MD | University Health Network - Princess Margaret Hospital |
Responsible Party: | University Health Network- Princess Margaret Hospital ( Drs. Lillian Siu and John Waldron ) |
Study ID Numbers: | APF-001 |
Study First Received: | August 6, 2008 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00731380 |
Health Authority: | Canada: Health Canada |
Abraxane Head and Neck Cancer Determine Maximum Tolerated dose |
ABI-007 Combination Cisplatin 5-Fluorouracil Patients |
Epidermoid carcinoma Cisplatin Paclitaxel Fluorouracil Squamous cell carcinoma |
Head and Neck Neoplasms Carcinoma, squamous cell Carboplatin Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |