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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00707473
Recruitment Status : Recruiting
First Posted : June 30, 2008
Last Update Posted : August 28, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if docetaxel, 5-fluorouracil, and either cisplatin or carboplatin in combination, then followed by chemoradiotherapy is effective in controlling cancers of the paranasal sinuses.

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Docetaxel
75 mg/m^2 IV on day 1 of each cycle.
Other Name: Taxotere

Drug: 5-Fluorouracil
750 mg/m^2 continuous infusion on days 1 through 4 of each cycle.
Other Names:
  • 5-FU
  • Adrucil
  • Efudex

Drug: Cisplatin
75 mg/m^2 IV over 30-120 minutes on day 1 of each cycle.
Other Names:
  • CDDP
  • Platinol®
  • Platinol®-AQ

Primary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have a confirmed (by a MDACC pathologist) cytologic or histological diagnosis of locally advanced squamous cell carcinoma, poorly differentiated carcinoma, or sinonasal undifferentiated carcinoma of the nasal cavity and/or 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. ECOG PS 0-1.
  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 >/= 100,000 cells/mm3;
  6. Hepatic Parameters: Total Bilirubin </= ULN; Alkaline Phosphatase </= 2 x ULN; AST and ALT </= 2 x ULN If the patient has a history of Gilbert's Syndrome, check direct and indirect bilirubin. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria.
  7. Hemoglobin >/= 10.0g/dL
  8. Per MDACC Creatinine clearance guidelines, patients must have a 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 uncontrolled intercurrent illness, which in the opinion of the attending medical oncologist, would render the patient unsuitable for the study (i.e., preclude safe administration of the prescribed chemotherapy treatment).
  10. Women Of Child Bearing Potential (WOCBP) must have a negative serum or urine pregnancy test (i.e., minimum sensitivity 25 IU/L or equivalent units of HCG), within 72 hours prior to the start of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician(s) immediately. **Refer to pg. 10 of the protocol for the formal definition of a WOCBP.**
  11. Ability to understand and the willingness to sign a written Informed Consent Document (ICD). In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC Policy For Consenting Non-English Speaking Participants.
  12. Willingness to undergo MDACC Audiology and Ophthalmology Assessment

Exclusion Criteria:

  1. Evidence of distant metastases (below the clavicle) by clinical or radiographic measures.
  2. Pre-existing peripheral neuropathy CTCAE grade 2 or worse
  3. Pre-existing bilateral sensorineural hearing loss at >90dB at any frequency from 250-8000Hz as assessed by a comprehensive audiometric evaluation for patients receiving cisplatin. This criteria will not apply to patients receiving carboplatin.
  4. Prior chemotherapy (i.e., as administered strictly for cancer treatment) within the previous 3 years. Use of chemotherapy agents for non-cancer treatment purposes (i.e., arthritis treatment, etc.) are excluded from this criterion.
  5. Prior radiotherapy to the paranasal sinus region or the upper neck (i.e., prior radiotherapy to another disease site is acceptable).
  6. Initial surgical resection of the paranasal sinuses or nasal cavity region rendering the patient clinically and radiologically disease free.
  7. Simultaneous primary invasive cancers or patients currently receiving any other investigational agents at time of study enrollment. Patients may have received investigational agents in the past. No washout time period is required.
  8. Patients with a past history of malignancy that were treated less than 3 years and have not remained disease free for the past 3 years. (Patients with non metastatic skin cancers will be eligible).
  9. 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).
  10. Women who are pregnant or breastfeeding.
  11. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. Please refer to Study Appendix O for a complete list of Polysorbate 80 containing drugs.
  12. Patients with a known history of HIV.

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 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
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Ehab Y. Hanna, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00707473     History of Changes
Other Study ID Numbers: 2007-0433
NCI-2010-01438 ( Registry Identifier: NCI CTRP )
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Paranasal Sinus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Nose Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs