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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020189 |
Purpose
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 |
|---|---|---|
|
Head and Neck Cancer Thromboembolism |
Drug: acetylsalicylic acid Drug: alvocidib Drug: clopidogrel bisulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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.
Eligibility| 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:
Contacts and Locations| 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) |
More Information
| ClinicalTrials.gov Identifier: | NCT00020189 History of Changes |
| Obsolete Identifiers: | NCT00005670 |
| Other Study ID Numbers: | CDR0000068028, NCI-00-C-0128, MB-401, NCI-T99-0066 |
| Study First Received: | July 11, 2001 |
| Last Updated: | May 9, 2009 |
| 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 |
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Thromboembolism Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Aspirin Ticlopidine |
Clopidogrel Flavopiridol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |