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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020189 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or metastatic head and neck cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer Thromboembolism |
Drug: acetylsalicylic acid Drug: alvocidib Drug: clopidogrel bisulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: Patients receive flavopiridol IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients also receive oral aspirin and clopidogrel bisulfate beginning on day 0 and continuing throughout the study.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 1-3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven squamous cell carcinoma of the head and neck
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Center for Cancer Research | |
Bethesda, Maryland, United States, 20892 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Barbara A. Conley, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000068028, NCI-00-C-0128, MB-401, NCI-T99-0066 |
Study First Received: | July 11, 2001 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00020189 History of Changes |
Health Authority: | United States: Federal Government |
thromboembolism untreated metastatic squamous neck cancer with occult primary 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 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 |
Anti-Inflammatory Agents Laryngeal Carcinoma Fibrinolytic Agents Squamous Cell Carcinoma Protein Kinase Inhibitors Thromboembolism Hypopharyngeal Cancer Fibrin Modulating Agents Aspirin Anti-Inflammatory Agents, Non-Steroidal Neoplasms, Squamous Cell Analgesics Salivary Gland Diseases Cyclooxygenase Inhibitors Vascular Diseases |
Carcinoma, Squamous Cell of Head and Neck Cardiovascular Agents Thrombosis Recurrence Carcinoma Flavopiridol Embolism and Thrombosis Metastatic Squamous Neck Cancer With Occult Primary Embolism Analgesics, Non-Narcotic Head and Neck Neoplasms Clopidogrel Epidermoid Carcinoma Platelet Aggregation Inhibitors Peripheral Nervous System Agents |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Fibrinolytic Agents Protein Kinase Inhibitors Thromboembolism Fibrin Modulating Agents Neoplasms by Site Aspirin Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal |
Growth Inhibitors Neoplasms, Squamous Cell Analgesics Neoplasms by Histologic Type Growth Substances Cyclooxygenase Inhibitors Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Thrombosis Pharmacologic Actions Carcinoma Flavopiridol Embolism and Thrombosis Neoplasms |