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Induction Therapy-Docetaxel, Cisplatin and Fluorouracil in Untreated Patients With Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, June 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
Sanofi-Aventis
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00707473
  Purpose

Primary Objectives:

  • To determine the clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF)
  • To improve local tumor control to 80% at 2 years

Secondary Objectives:

  • Disease specific-survival and overall survival rates
  • Organ preservation (orbital, maxillary, cranial) rate
  • Patterns of treatment failure (local, regional, and distant)
  • Acute and late treatment-related toxicity
  • The effect of treatment on Quality of Life with and without surgery
  • To evaluate the effects of induction chemotherapy on biological markers that could serve as surrogates for response and predictors of long-term outcome.

Condition Intervention Phase
Paranasal Sinuses
Squamous Cell Carcinoma
Drug: Docetaxel
Drug: 5-Fluorouracil
Drug: Cisplatin
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Docetaxel    Cisplatin    Fluorouracil    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase II Trial of Induction Therapy With Docetaxel, Cisplatin and Fluorouracil in Previously Untreated Patients With Locally Advanced Squamous Cell or Undifferentiated Carcinoma of the Paranasal Sinuses

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this clinical research study is to learn if docetaxel, cisplatin, and 5-fluorouracil in combination can help to control the disease in patients with cancer of the paranasal sinuses. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:   45
Study Start Date:   June 2008
Estimated Primary Completion Date:   June 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Docetaxel, Cisplatin, and 5-Fluorouracil
Drug: Docetaxel
75 mg/m^2 IV on day 1 of each cycle.
Drug: 5-Fluorouracil
750 mg/m^2 continuous infusion on days 1 through 4 of each cycle.
Drug: Cisplatin
75 mg/m^2 IV over 30-120 minutes on day 1 of each cycle.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Patients with cytologic or histological diagnosis of squamous cell carcinoma or poorly differentiated carcinoma of the nasal cavity and paranasal sinuses.
  2. 2. Stage II-IV disease; T 2-4, N any, M0. Measurable disease is required with the following criteria: Measurable lesions can be accurately measured, with at least one diameter >\= 1.0 cm by spiral CT scan or MRI. Lesions can be bidimensionally measurable or unidimensionally measurable. Every effort should be made to measure lesions in two dimensions. Measurable disease is present if the patient has one or more measurable lesions. Non-measurable lesions/disease are all other lesions, including small lesions (those with measurements < 2.0 cm; or < 1.0 cm with spiral CT).
  3. Karnofsky performance status of >\= 70 or ECOG PS 0-2.
  4. Age > 16 years.
  5. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of >/= 1500 cells/mm3 and platelet count of >/= 140,000 cells/mm3;
  6. Hepatic Parameters: Total Bilirubin </= ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. **Refer to table in protocol pg.6**
  7. Hemoglobin >/= 10.0g/dL
  8. Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 CrCl female = 0.85 x (CrCl male)
  9. Patients should have no debilitating acute or chronic co-morbid condition, or acute serious infection that in the opinion of the attending medical oncologist would preclude safe administration of the prescribed chemotherapy treatment.
  10. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
  11. Patients must sign a study-specific informed consent form.

Exclusion Criteria:

  1. Histology other than squamous cell or poorly differentiated carcinoma.
  2. Evidence of distant metastases (below the clavicle) by clinical or radiographic measures.
  3. Karnofsky performance status < 70 or ECOG>2 (Appendices B and BB).
  4. Pre-existing peripheral neuropathy CTCAE grade 2 or worse or pre-existing severe bilateral hearing deficits.
  5. Prior chemotherapy, within the previous 3 years.
  6. Prior radiotherapy to the paranasal sinus region or the upper neck.
  7. Initial surgical resection rendering the patient clinically and radiologically disease free.
  8. Simultaneous primary invasive cancers.
  9. Patients with a past history of malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free).
  10. Men and Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the study. Subjects who are men must also agree to use effective contraception. Note: WOCBP must be using an adequate method of contraception throughout the study and for up to 3 months after the study. Adequate methods of contraception will include (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
  11. Women who are pregnant or breastfeeding.
  12. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707473

Contacts
Contact: Ehab Y. Hanna, MD     713-745-2672    

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Ehab Y. Hanna, MD            

Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi-Aventis

Investigators
Principal Investigator:     Ehab Y. Hanna, MD     U.T. M.D. Anderson Cancer Center    
  More Information


Responsible Party:   U.T. M.D. Anderson Cancer Center ( Ehab Y. Hanna, M.D. / Professor )
Study ID Numbers:   2007-0433
First Received:   June 26, 2008
Last Updated:   June 27, 2008
ClinicalTrials.gov Identifier:   NCT00707473
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Carcinoma of Paranasal Sinuses  
Paranasal Sinuses  
Nasal Sinuses  
Nasal Cavity  
Squamous Cell Carcinoma  
Undifferentiated Carcinoma
Poorly Differentiated Carcinoma
Docetaxel
5-Fluorouracil
Cisplatin

Study placed in the following topic categories:
Docetaxel
Epidermoid carcinoma
Cisplatin
Fluorouracil
Squamous cell carcinoma
Salicylsalicylic acid
Sodium Salicylate
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008




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