Know Cancer

or
forgot password

A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx


OBJECTIVES:

- Determine the organ preservation rate in patients with stage III or IV squamous cell
carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed
by paclitaxel with concurrent radiotherapy.

- Determine the feasibility and toxicity of this regimen in these patients.

- Determine the utility of pre- and post-treatment organ function instruments on
swallowing ability and voice quality in patients treated with this regimen.

- Determine the disease-free survival and patterns of failure of patients treated with
this regimen.

- Determine the objective tumor response rate (complete and partial response) in these
patients following treatment with 2 courses of induction therapy with paclitaxel and
carboplatin.

- Determine changes in quality of life of patients treated with this regimen.

- Determine whether the presence of human papilloma virus infection and p-glycoprotein
correlates with outcome in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to disease site
(larynx vs oropharynx).

Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by
carboplatin IV over 30-60 minutes on days 1 and 22. Within 28 days after completion of
induction therapy, patients with responding or stable disease receive paclitaxel IV over 60
minutes on days 1, 8, 15, 22, 29, 36, and 43 and radiotherapy once daily, 5 times weekly,
for 7 weeks beginning on day 1.

Within 6-8 weeks after completion of therapy, patients who initially had bulky neck disease
(N3) or who have residual palpable lymphadenopathy undergo surgical neck dissection.
Patients with N1-N2 disease with complete response may also undergo neck dissection.
Patients with initial complete response who recur at the primary site undergo surgical
salvage.

Quality of life is assessed at baseline, after induction therapy, and at 3, 12, and 24
months after completion of all therapy.

Patients are followed at 6 weeks, 3 months, every 6-8 weeks for 1 year, every 3 months for 1
year, every 4 months for 1 year, and then every 6 months for 5 years thereafter.

PROJECTED ACCRUAL: A total of 110 patients (55 per stratum) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the
larynx or oropharynx

- No recurrent disease

- No evidence of distant metastasis

- Resectable disease, defined as follows:

- High probability of attaining clear surgical margins (for disease of the base of
tongue, tonsil, soft palate, or pharyngeal wall)

- No extension to root of tongue (for disease of the base of tongue)

- No extension into pterygoid by radiograph (for disease of the tonsil, soft
palate, or pharyngeal wall)

- No primary tumor or nodal metastases fixed to the carotid artery or cervical
spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal
wall)

- No trismus (for disease of the tonsil, soft palate, or pharyngeal wall)

- No involvement of the trachea greater than 1 cm or any involvement of the
esophagus (for disease of the subglottis)

- For disease of the supraglottis, glottis, or subglottis:

- No base of the tongue invasion greater than 2 cm

- No tumor extension through cartilage to involve strap muscles of the neck

- No tumor fixation to prevertebral fascia

- No involvement of the carotid artery

- No fixed nodal disease with involvement of the deep neck

- Extension into pyriform sinus or lateral pharyngeal wall allowed if no
extension into posterior pharynx

- Measurable disease

- - Lesions accurately measured in at least one dimension as > 20 mm (2.0 cm) with
conventional techniques or as > 10 mm (1.0 cm) with spiral CT scan

- Cytologic or histologic evidence of neoplasm is needed for measurable disease
restricted to a solitary lesion

- No other concurrent head and neck neoplasms

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Not specified

Renal

- Creatinine less than 3.0 mg/dL

- Calcium normal

Cardiovascular

- No significant cardiac disease

- No uncontrolled hypertension

- No unstable angina

- No congestive heart failure

- No myocardial infarction within the past year

- No serious cardiac arrhythmias requiring medication

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after study completion

- No significant detectable infection

- No history of allergy to drugs containing Cremophor EL

- No history of allergy to mammalian cell-derived products (epoetin alfa) or human
albumin

- No other malignancy within the past 3 years except basal or squamous cell skin cancer
or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

- No concurrent amifostine

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy above the clavicles

Surgery

- No prior surgery to the primary tumor except biopsy or debulking

Other

- No concurrent experimental mucosal protectants

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Organ preservation rate

Safety Issue:

No

Principal Investigator

Anthony J. Cmelak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068468

NCT ID:

NCT00014118

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms
  • Laryngeal Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Wesley Medical CenterWichita, Kansas  67214
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Southwest Medical CenterLiberal, Kansas  67901
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Guthrie Cancer Center at Guthrie Clinic SayreSayre, Pennsylvania  18840
Watson Clinic, LLCLakeland, Florida  33804-5000