RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with metastatic or recurrent salivary gland cancer.

Condition	Treatment or Intervention	Phase
stage IV salivary gland cancer recurrent salivary gland cancer high-grade salivary gland mucoepidermoid carcinoma salivary gland adenocarcinoma	Drug: paclitaxel	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

California
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States
      Veterans Affairs Medical Center - Palo Alto, Palo Alto,  California,  94304,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States
Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States
      Veterans Affairs Medical Center - Chicago (Lakeside), Chicago,  Illinois,  60611,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States
Tennessee
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
      Veterans Affairs Medical Center - Nashville, Nashville,  Tennessee,  37212,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States
      Veterans Affairs Medical Center - Madison, Madison,  Wisconsin,  53705,  United States
South Africa
      Pretoria Academic Hospital, Pretoria,  0001,  South Africa

Study chairs or principal investigators

Harlan A. Pinto,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000064057; E-1394; ECOG-1394
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002632
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08