- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002632
Paclitaxel in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
PHASE II TRIAL OF TAXOL IN ADVANCED OR METASTATIC SALIVARY GLAND MALIGNANCIES
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.
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pretoria, South Africa, 0001
- Pretoria Academic Hospital
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California
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Palo Alto, California, United States, 94304
- Veterans Affairs Medical Center - Palo Alto
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Stanford, California, United States, 94305-5408
- Stanford University Medical Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, United States, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Chicago, Illinois, United States, 60611
- Veterans Affairs Medical Center - Chicago (Lakeside)
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Oncology Center
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, United States, 68131
- CCOP - Missouri Valley Cancer Consortium
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New Jersey
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East Orange, New Jersey, United States, 07018-1095
- Veterans Affairs Medical Center - East Orange
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Comprehensive Cancer Center
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Rochester, New York, United States, 14642
- University of Rochester Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19102-1192
- Hahnemann University Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Cancer Institute
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt Cancer Center
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Nashville, Tennessee, United States, 37212
- Veterans Affairs Medical Center - Nashville
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Wisconsin
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Madison, Wisconsin, United States, 53705
- Veterans Affairs Medical Center - Madison
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Harlan A. Pinto, MD, Stanford University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Stomatognathic Diseases
- Mouth Diseases
- Salivary Gland Diseases
- Mouth Neoplasms
- Salivary Gland Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- CDR0000064057
- E-1394
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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