Clinical trial NCT00002632: Paclitaxel in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
Official title: PHASE II TRIAL OF TAXOL IN ADVANCED OR METASTATIC SALIVARY GLAND MALIGNANCIES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: stage IV salivary gland cancer
recurrent salivary gland cancer
high-grade salivary gland mucoepidermoid carcinoma
salivary gland adenocarcinoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Medical Center - Palo Alto
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Decatur
country: United States
facility: Veterans Affairs Medical Center - Atlanta (Decatur)
state: Georgia
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Veterans Affairs Medical Center - Chicago (Lakeside)
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Ann Arbor
country: United States
facility: CCOP - Ann Arbor Regional
state: Michigan
city: Duluth
country: United States
facility: CCOP - Duluth
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: East Orange
country: United States
facility: Veterans Affairs Medical Center - East Orange
state: New Jersey
city: Hackensack
country: United States
facility: CCOP - Northern New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Albert Einstein Comprehensive Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Cancer Center
state: Tennessee
city: Madison
country: United States
facility: Veterans Affairs Medical Center - Madison
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital
Study officials:
affiliation: Stanford University
name: Harlan A. Pinto, MD
role: STUDY_CHAIR
References:
citation: Gilbert J, Li Y, Pinto HA, Jennings T, Kies MS, Silverman P, Forastiere AA. Phase II trial of taxol in salivary gland malignancies (E1394): a trial of the Eastern Cooperative Oncology Group. Head Neck. 2006 Mar;28(3):197-204. doi: 10.1002/hed.20327.
citation: Jennings T, Li Y, Pinto H, et al.: Phase II trial of paclitaxel in advanced or metastatic salivary gland malignancies: an Eastern Cooperative Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-942, 2001.