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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: June 26, 2008
Last updated: February 13, 2015
Last verified: February 2015

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

Condition Intervention Phase
Paranasal Sinus Neoplasms
Squamous Cell Carcinoma
Drug: Docetaxel
Drug: 5-Fluorouracil
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 or Undifferentiated Carcinoma of the Paranasal Sinuses

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Number of Patients with Complete + Partial Response [ Time Frame: Response assessment after two 3 week cycles, then every 6 months for minimally 2 years ] [ Designated as safety issue: No ]
    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).

Estimated Enrollment: 45
Study Start Date: June 2008
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Inclusion Criteria:

  1. Within 12 weeks prior to study entry, patients must have a confirmed cytologic or histological diagnosis of locally advanced squamous cell carcinoma and/or poorly differentiated carcinoma of the nasal cavity and/or paranasal sinuses. If the biopsy was collected outside of MDACC, the MDACC Pathology Department must assess and confirm the SCC diagnosis.
  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 0-1.
  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 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. 10**
  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 no substantial concomitant medical 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. Histology other than locally advanced squamous cell carcinoma and/or poorly differentiated carcinoma of the nasal cavity and paranasal sinuses.
  2. Evidence of distant metastases (below the clavicle) by clinical or radiographic measures.
  3. Karnofsky performance status < 70 or ECOG>1 (Appendices B and BB).
  4. Pre-existing peripheral neuropathy CTCAE grade 2 or worse or pre-existing severe bilateral hearing deficits.
  5. 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.
  6. Prior radiotherapy to the paranasal sinus region or the upper neck (i.e., prior radiotherapy to another disease site is acceptable).
  7. Initial surgical resection of the paranasal sinuses or nasal cavity region rendering the patient clinically and radiologically disease free.
  8. 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.
  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. Please refer to Study Appendix O for a complete list of Polysorbate 80 containing drugs.
  13. Patients with a history of HIV or Hepatitis C.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00707473

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

United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Ehab Y. Hanna, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Ehab Y. Hanna, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00707473     History of Changes
Other Study ID Numbers: 2007-0433, NCI-2010-01438
Study First Received: June 26, 2008
Last Updated: February 13, 2015
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

Additional relevant MeSH terms:
Paranasal Sinus Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Nose Diseases
Nose Neoplasms
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents processed this record on March 25, 2015