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Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma


OBJECTIVES:

- Determine the response rate in patients with metastatic or locally recurrent head and
neck cancer treated with irinotecan and docetaxel.

- Determine the progression-free and overall survival of patients treated with this
regimen.

- Determine the toxic effects of this regimen in these patients.

- Correlate angiogenesis markers and cyclooxygenase-2 expression with response and
survival in patients treated with this regimen.

- Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (no prior chemotherapy for locally recurrent or metastatic disease or more than
6 months since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for
locally recurrent or metastatic disease or less than 6 months since prior chemotherapy as
primary therapy).

Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on
days 1 and 8. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 32-72 patients (16-36 per stratum) will be accrued for this
study within 6-14 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed carcinoma of the head and neck

- Squamous cell carcinoma

- No WHO grade II or III nasopharyngeal carcinoma (well-differentiated
nasopharyngeal carcinoma allowed)

- Metastatic or locally recurrent disease considered to be incurable by locoregional
therapy

- Unidimensionally measurable disease outside previously irradiated field unless
documented progressive disease or histologically confirmed residual carcinoma at
least 8 weeks after completion of radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

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

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

Hepatic:

- Bilirubin normal

- AST and ALT less than 2.5 times upper limit of normal (ULN) and alkaline phosphatase
normal OR

- Alkaline phosphatase less than 4 times ULN and AST and ALT normal

Renal:

- Creatinine less than 2.0 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- No active infection

- No pre-existing grade 2 or greater peripheral neuropathy

- No other concurrent medical condition that would preclude study participation

- No hypersensitivity to drugs formulated with Polysorbate 80

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 2 weeks since prior biologic therapy

- Any number of prior biologic therapies (e.g., chimeric antibodies or kinase
inhibitors) allowed

- No concurrent filgrastim (G-CSF)

Chemotherapy:

- At least 4 weeks since prior chemotherapy

- No prior docetaxel or irinotecan

- No more than 1 prior chemotherapy regimen for recurrent or metastatic disease

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy for recurrent or metastatic disease and
recovered

Surgery:

- Recovered from prior surgery

Other:

- No concurrent antiepileptics

- No concurrent cyclosporine

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Athanassios Argiris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069408

NCT ID:

NCT00040807

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • salivary gland squamous cell carcinoma
  • stage IV salivary gland cancer
  • Head and Neck Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Northern New JerseyHackensack, New Jersey  07601
Boulder Community HospitalBoulder, Colorado  80301-9019
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - EvanstonEvanston, Illinois  60201
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - OklahomaTulsa, Oklahoma  74136
Albert Einstein Clinical Cancer CenterBronx, New York  10461
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Tufts - New England Medical CenterBoston, Massachusetts  02111
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Penrose Cancer CenterColorado Springs, Colorado  80933
Medical Center of Aurora - South CampusAurora, Colorado  80012-0000
Rocky Mountain Cancer Centers - Denver RoseDenver, Colorado  80220
Rocky Mountain Cancer Centers - ThorntonThornton, Colorado  80229