Houston, Texas 77030


Purpose:

This phase II trial studies how well docetaxel, cisplatin and fluorouracil work in treating patients with previously untreated stage II-IV nasal cavity and/or paranasal sinus cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


Study summary:

PRIMARY OBJECTIVES: I. To determine the clinical/radiographic complete and partial response rate after induction chemotherapy with docetaxel, cisplatin and fluorouracil (TPF). II. To improve local tumor control to 80% at 2 years. SECONDARY OBJECTIVES I. Disease specific-survival and overall survival rates. II. Organ preservation (orbital, maxillary, cranial) rate. III. Patterns of treatment failure (local, regional, and distant). IV. Acute and late treatment-related toxicity. V. The effect of treatment on Quality of Life with and without surgery (i.e., M. D. Anderson Symptom Inventory [MDASI], M. D. Anderson Dysphagia Inventory [MDADI], Xerostomia Questionnaire, Performance Status Scale for Head & Neck Cancer Patients [PSS-HN], etc.). VI. To evaluate the effects of induction chemotherapy on biological markers that could serve as surrogates for response and predictors of long-term outcome. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive docetaxel intravenously (IV) over 1 hour on day 1, cisplatin IV over 30-180 minutes or carboplatin IV on day 1, and fluorouracil IV continuously on days 1-4. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) or partial response (PR) receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have stable disease (SD) or progressive disease (PD) to induction therapy, or less than a complete response to chemoradiotherapy undergo surgery and radiation therapy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 4 months for 1 year and every 6 months for 2 years.


Criteria:

Inclusion Criteria: - Patients must have a confirmed (by a MD Anderson Cancer Center [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. - Stage II-IV disease; tumor (T) 2-4, node (N) any, metastasis (M) 0. Measurable disease is required with the following criteria: Measurable lesions can be accurately measured, with at least one diameter >= 1.0 cm by spiral computed tomography (CT) scan or magnetic resonance imaging (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). - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. - Absolute peripheral granulocyte count (AGC) of >= 1500 cells/mm^3. - Platelet count of >= 100,000 cells/mm^3. - Total bilirubin =< upper limit of normal (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. - Alkaline phosphatase =< 2 x ULN. 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. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x ULN. 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. - Hemoglobin >= 10.0g/dL. - Per MDACC creatinine clearance (CrCl) guidelines, patients must have a creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram - 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). - 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 human chorionic gonadotropin [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. - 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. - Willingness to undergo MDACC Audiology and Ophthalmology Assessment. Exclusion Criteria: - Evidence of distant metastases (below the clavicle) by clinical or radiographic measures. - Pre-existing peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or worse. - 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. - 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. - Prior radiotherapy to the paranasal sinus region or the upper neck (i.e., prior radiotherapy to another disease site is acceptable). - Initial surgical resection of the paranasal sinuses or nasal cavity region rendering the patient clinically and radiologically disease free. - 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. - 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). - 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). - Women who are pregnant or breastfeeding. - Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. - Patients with a known history of human immunodeficiency virus (HIV).


Study is Available At:


Original ID:

2007-0433


NCT ID:

NCT00707473


Secondary ID:

NCI-2018-01810


Study Acronym:


Brief Title:

Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

17 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

45


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ehab Y Hanna
Principal Investigator
M.D. Anderson Cancer Center
Primary Contact:Ehab Hanna
713-745-2672
eyhanna@mdanderson.org

Study Dates

Start Date:June 16, 2008
Completion Date:June 30, 2021
Completion Type:Anticipated
Primary Completion Date:June 30, 2021
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 27, 2019
First Received Date:June 26, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Biological markers
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Quality of Life with and without surgery
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Late treatment-related toxicity
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Acute treatment-related toxicity
Time Frame:U to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patterns of treatment failure (local, regional, and distant)
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Organ preservation (orbital, maxillary, cranial) rate
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall survival rate
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Disease specific-survival rate
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Local tumor control to 80%
Time Frame:At 2 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clinical/radiographic complete rate after induction chemotherapy with docetaxel, cisplatin, and fluorouracil
Time Frame:Up to 5 years
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Carboplatin
Description:Given IV
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Other Name:Blastocarb
Intervention Type:Other
Name:Chemoradiotherapy
Description:Undergo chemoradiotherapy
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Other Name:chemoradiation
Intervention Type:Drug
Name:Cisplatin
Description:Given IV
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Other Name:Abiplatin
Intervention Type:Procedure
Name:Definitive Surgical Resection
Description:Undergo surgery
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Intervention Type:Drug
Name:Docetaxel
Description:Given IV
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Other Name:Docecad
Intervention Type:Drug
Name:Fluorouracil
Description:Given IV
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Other Name:5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Intervention Type:Procedure
Name:Quality-of-Life Assessment
Description:Correlative studies
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Other Name:Quality of Life Assessment
Intervention Type:Radiation
Name:Radiation Therapy
Description:Undergo radiation therapy
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Other Name:Cancer Radiotherapy

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (docetaxel, cisplatin, and fluorouracil)
Description:INDUCTION CHEMOTHERAPY: Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 30-180 minutes or carboplatin IV on day 1, and fluorouracil IV continuously on days 1-4. Cycles repeat every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve CR or PR receive 1 additional course of treatment and undergo chemoradiotherapy over 6-7 weeks. Patients who have SD or PD to induction therapy, or less than a complete response to che

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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