Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma and/or Poorly Differentiated Carcinoma of the Nasal Cavity and/or Paranasal Sinuses
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|ClinicalTrials.gov Identifier: NCT00707473|
Recruitment Status : Recruiting
First Posted : June 30, 2008
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Paranasal Sinus Neoplasms Squamous Cell Carcinoma||Drug: Docetaxel Drug: 5-Fluorouracil Drug: Cisplatin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma and/or Poorly Differentiated Carcinoma of the Nasal Cavity and/or Paranasal Sinuses|
|Actual Study Start Date :||June 2008|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Docetaxel, Cisplatin, and 5-Fluorouracil
Docetaxel 75 mg/m^2 IV on day 1 of each cycle. Cisplatin 75 mg/m^2 IV over 30-120 minutes on day 1 of each cycle. 5-Fluorouracil 750 mg/m^2 continuous infusion on days 1 through 4 of each cycle.
75 mg/m^2 IV on day 1 of each cycle.
Other Name: TaxotereDrug: 5-Fluorouracil
750 mg/m^2 continuous infusion on days 1 through 4 of each cycle.
Other Names:Drug: Cisplatin
75 mg/m^2 IV over 30-120 minutes on day 1 of each cycle.
- Number of Patients with Complete + Partial Response [ Time Frame: Response assessment after two 3 week cycles, then every 6 months for minimally 2 years ]Clinical/radiographic complete and partial responses after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF) where Complete Response (CR): Disappearance of clinical and radiological evidence of tumor; Partial Response (PR): 50% or > decrease in overall sum of products of diameters of all target lesions in reference to baseline sum. PR defined as a 30% or > reduction in dimension target lesions; Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; Progressive Disease (PD): 25% or > increase in overall sum products of diameters of all target lesions reference smallest sum recorded at or following baseline. PD is defined as a 20% or > increase in dimension of target lesions. Tumors measurable by only one dimension assessed by Response Evaluation Criteria In Solid Tumors (RECIST).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707473
|Contact: Ehab Y. Hanna, MD||713-745-2672|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ehab Y. Hanna, MD||M.D. Anderson Cancer Center|