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PHASE II TRIAL OF TAXOL IN ADVANCED OR METASTATIC SALIVARY GLAND MALIGNANCIES


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

Thank you

Trial Information

PHASE II TRIAL OF TAXOL IN ADVANCED OR METASTATIC SALIVARY GLAND MALIGNANCIES


OBJECTIVES: I. Estimate the response rate in patients with metastatic or recurrent salivary
gland cancer treated with paclitaxel (Taxol, TAX) by 3-hour infusion. II. Describe the
toxicity of TAX in these patients.

OUTLINE: Single-Agent Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, TAX, NSC-125973.

PROJECTED ACCRUAL: Up to 32 patients/histology will be entered. If no response is observed
in the first 14 patients in a particular histology, accrual to that group will close; if
after 18 months annual accrual is less than 10 patients/histology, accrual to that group may
close.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed salivary gland carcinoma that is
metastatic or recurrent, including the following types: Mucoepidermoid carcinoma
Adenocarcinoma Pathology review required Measurable disease required Lesion in a
previously irradiated field must be progressing and biopsy- proven

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC
at least 3,000/mm3 ANC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hb at least
10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0
mg/dL Cardiovascular: No MI within the past 6 months No CHF No unstable arrhythmia No
current antiarrhythmic, inotropic, or antianginal medication Other: No history of allergy
to Cremophor No prior malignancy within 5 years except: Curatively treated nonmelanomatous
skin cancer Curatively treated in-situ cancer of the cervix No concurrent malignancy Not
pregnant or nursing Effective contraception strongly advised for fertile patients
Blood/body fluid analyses to determine eligibility and imaging studies and scans/x-rays
for tumor measurement completed within 14 days prior to registration

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological response modifier therapy
allowed Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy:
Prior radiotherapy allowed with recovery Surgery: Prior surgery allowed with recovery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Harlan A. Pinto, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000064057

NCT ID:

NCT00002632

Start Date:

March 1995

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage IV salivary gland cancer
  • recurrent salivary gland cancer
  • high-grade salivary gland mucoepidermoid carcinoma
  • salivary gland adenocarcinoma
  • Head and Neck Neoplasms
  • Salivary Gland Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212