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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


Phase 2
17 Years
N/A
Open (Enrolling)
Both
Paranasal Sinus Neoplasms, Squamous Cell Carcinoma

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Trial Information

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


The Study Drugs:

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
It is believed to be weakly effective at killing blood vessels in cancer cells as well.

Cisplatin has an atom at its center that contains platinum. The platinum is supposed to
poison the cancer cells, which may cause them to die.

5-Fluorouracil is designed to destroy cancer cells by preventing them from dividing and
multiplying .

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive 5-fluorouracil
through a needle in your vein, non-stop, on Days 1-4 of each 21-day study "cycle". On Day 1
only, you will receive docetaxel over 1 hour and cisplatin over 30-180 minutes. You will
receive 2-3 cycles of therapy.

If you are having side effects, the study doctor may schedule you to receive the study drugs
on a longer cycle.

Study Visits:

During Weeks 1-3 of Cycles 1 and 2, you will have study visits during the week that you
receive chemotherapy treatment. At these visits, the following tests and procedures will be
performed:

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Your medical history will be recorded, including measurement of your height and weight.

- Your doctor will ask about any side effects you may be experiencing.

- You will have a physical exam, including measurement of your vital signs.

- Your skin and inside of your mouth will be examined by your doctor.

- You will be asked how well you are able to perform the normal activities of daily
living (performance status evaluation).

- You will have a hearing test.

Once Cycle 2 is completed, you will have the following tests and procedures performed to
learn if the disease has responded to the therapy:

- Blood (about 2 teaspoons) will be collected for routine tests.

- You will have a physical exam, including measurement of your vital signs.

- Your medical history will be recorded, including measurement of your height and weight.

- You will have a nasal endoscopy.

- You will have a CT or MRI scan to check the status of the disease.

- Your doctor will ask about any side effects you may be experiencing.

- Your performance status will be checked.

- The nerve function in your head and neck will be checked by hand.

- If your doctor thinks it is necessary, you will have a chest x-ray.

- If your doctor thinks it is necessary, you will have bone scans.

- If your liver tests were abnormal and your doctor thinks it it is necessary, you will
have a CT scan of your abdomen.

- If your doctor thinks it is necessary, you will have a positron emission tomography
(PET) or PET-CT.

- You will have an eye exam.

Chemotherapy or Radiotherapy:

Based on the results of the tests and procedures performed to check to see if the disease
has responded, your doctor will decide your next treatment.

If you respond partly or completely, you will receive a 3rd cycle of chemotherapy. You will
follow the same schedule as you did during the first 2 cycles. Once you complete the 3
cycles of chemotherapy, you will begin chemoradiation. Your doctor will discuss this with
you in more detail and you will receive a separate consent form.

If the disease does not respond partly or completely, you will have surgery followed by
radiotherapy. Before surgery, you will be asked to sign a separate informed consent. Risks
will be discussed with your treating doctor and will depend on the type of surgery. Before
radiotherapy, you will be asked to sign a separate informed consent that will describe
possible risks.

Additional Cycles:

If the disease responds partly or completely, you will receive an additional (third) cycle
of therapy. If you have the additional cycle, you will follow the same schedule as you did
during Cycles 1 and 2. Before you receive the additional cycle, you will have a hearing
test.

Study Visit After Chemoradiation:

If you receive chemoradiation, after your last chemotherapy treatment you will have the
following tests and procedures performed:

- You will have a physical exam, including measurement of your vital signs.

- Your medical history will be recorded, including measurement of your height and weight.

- The nerve function in your head and neck will be checked by hand.

- You will have a nasal endoscopy.

- You will have an MRI.

- Your doctor will ask about any side effects you may be experiencing.

- If your doctor thinks it is necessary, you will also have a CT or positron emission
tomography (PET)-CT scan.

Length of Study:

You will remain on study treatment for 16-20 weeks. You will be taken off study early if the
disease gets worse or intolerable side effects occur.

Follow-up/End-of-Treatment Visits:

If the disease responded completely while you were on study, you will have follow-up visits
every 3 months during Years 1-2, every 4 months during Year 3, and every 6 months during
Years 4-5. If the disease did not respond completely and you are having side effects at the
end-of-study visit, you will have follow-up visits every 4 weeks until the side effects go
away. At each visit, the following tests and procedures will be performed:

- Your complete medical history will be recorded, including measurement of your height
and weight.

- You will have a physical exam, including measurement of your vital signs.

- You will have a nasal endoscopy.

- The nerve function in your head and neck will be checked.

- Your doctor will ask about any side effects you may be experiencing.

- Your performance status will be checked.

- One (1) time each year, blood (about 2 teaspoons) will be drawn for a thyroid function
test.

If the disease responded completely while you were on study, additional tests and procedures
will also be performed at 6 months during Year 1, then yearly during Years 1-3. The
following tests will also be performed:

- You will have an eye exam.

- You will have a hearing test.

- You will have a dental exam.

- You will complete a questionnaire that will ask you to rate your symptoms and how much
they may interfere with your daily activities. This will take about 10 minutes to
complete.

- You will have saliva flow tests.

- You will have a CT or MRI scan to check the status of the disease.

- If your doctor thinks it is necessary, you will have a chest x-ray.

- If your doctor thinks it is necessary, you will have bone scans.

- If your liver tests were abnormal and your doctor thinks it it is necessary, you will
have a CT scan of your abdomen.

- If your doctor thinks it is necessary, you will have a positron emission tomography
(PET) or PET-CT.

This is an investigational study. Docetaxel is FDA approved for the treatment of certain
types of breast cancer, gastric cancer, prostate cancer, and advanced squamous cell
carcinoma of the head and neck.

Cisplatin is FDA approved to be used together with other drugs to treat advanced ovarian
cancer, testicular cancer, locally advanced squamous cell carcinoma of the head and neck,
late-stage cervical cancer, and non-small cell lung cancer.

5-fluorouracil is FDA approved to be used with other drugs to treat metastatic colorectal
cancer, locally advanced squamous cell carcinoma of the head and neck, and gastric
adenocarcinoma.

The use of these drugs to treat cancer of the nasal cavity or paranasal sinuses is
investigational.

Up to 45 patients will take part in this study. All will be enrolled at M. D. Anderson.


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 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Complete + Partial Response

Outcome Description:

Clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF).

Outcome Time Frame:

Response assessment after two 3 week cycles, then every 6 months for minimally 2 years

Safety Issue:

No

Principal Investigator

Ehab Y. Hanna, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0433

NCT ID:

NCT00707473

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Paranasal Sinus Neoplasms
  • Squamous Cell Carcinoma
  • Carcinoma of Paranasal Sinuses
  • Paranasal Sinuses
  • Nasal Sinuses
  • Nasal Cavity
  • Squamous Cell Carcinoma
  • Undifferentiated Carcinoma
  • Poorly Differentiated Carcinoma
  • Docetaxel
  • 5-Fluorouracil
  • Cisplatin
  • Platinol┬«
  • Platinol┬«-AQ
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Paranasal Sinus Neoplasms

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030