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Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00080028
Recruitment Status : Terminated
First Posted : March 23, 2004
Last Update Posted : May 8, 2007
Sponsor:
Information provided by:
Pharmacyclics LLC.

Brief Summary:
The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oropharynx Cancer Larynx Cancer Hypopharynx Cancer Drug: Motexafin Gadolinium Injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck






Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Each patient must sign a study-specific informed consent form
  • Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI
  • Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin
  • Karnofsky Performance Status score of at least 60%
  • Primary tumor at least 4 cm in diameter

Exclusion Criteria:

Laboratory Values of:

  • Serum creatinine > 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min
  • Serum total bilirubin > 1.5 times the upper limit of normal
  • ALT (formerly SGPT) > 1.5 times the upper limit of normal
  • Alkaline phosphatase > 1.5 times the upper limit of normal
  • Absolute neutrophil count (ANC) < 1500/L
  • Platelet count < 100,000/L
  • 3+ or greater proteinuria on urinalysis

and

  • Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx
  • Distant metastases
  • Prior history of cancer at any site treated with radiotherapy and/or chemotherapy
  • History of SCCHN diagnosed within 5 years of current diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080028


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Texas
University of Texas, San Antonio Health Science Center
San Antonio, Texas, United States
Sponsors and Collaborators
Pharmacyclics LLC.

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ClinicalTrials.gov Identifier: NCT00080028     History of Changes
Other Study ID Numbers: PCYC-0210
First Posted: March 23, 2004    Key Record Dates
Last Update Posted: May 8, 2007
Last Verified: May 2007
Keywords provided by Pharmacyclics LLC.:
Head and Neck Cancer
SCCHN
Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer
Soft palate Cancer
Tonsil Cancer
Base of tongue Cancer
Supraglottic Cancer
Glottic Cancer
Pyriform Sinus Cancer
Pharyngeal wall Cancer
Throat cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents