Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer

NCT00003327 | Unknown Phase 2

• 4 other identifiers: CDR0000066279THERADEX-B97-5250BMS-TAX/MEN.05NCI-V98-1415
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 20

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 recurrent or refractory head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage IV nasopharyngeal cancer; recurrent nasopharyngeal cancer; stage IV lip and oral cavity cancer; recurrent lip and oral cavity cancer; stage IV hypopharyngeal cancer; recurrent hypopharyngeal cancer; stage IV laryngeal cancer; recurrent laryngeal cancer; stage IV paranasal sinus and nasal cavity cancer; recurrent paranasal sinus and nasal cavity cancer; stage IV oropharyngeal cancer; recurrent oropharyngeal cancer

Interventions

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory head and neck cancer Measurable or evaluable disease At least one prior chemotherapy regimen for recurrent or metastatic disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Calcium within normal limits Cardiovascular: No New York Heart Association class III-IV heart disease No myocardial infarction within 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusions or arrhythmias Neurologic: No peripheral neuropathy greater than grade 1 Other: Not pregnant or nursing Fertile patients must use effective contraceptive method Negative pregnancy test No active infection or serious underlying medical condition No history of hypersensitivity to drugs containing Cremophor (teniposide, cyclosporine, or vitamin K) No prior invasive malignancies within the past 2 years, except: Curatively treated basal or squamous cell carcinoma of the skin Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 5 weeks since prior nitrosoureas, melphalan, or mitomycin At least 3 weeks since other prior chemotherapy Prior taxane therapy allowed only if administered on a 3 week or greater schedule No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy Concurrent megestrol (Megace) allowed No other concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to greater than 30% of bone marrow No concurrent radiotherapy Surgery: At least 3 weeks since major surgery Other: At least 1 week since prior parenteral antibiotics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Theradex: lead

Study Sites (20)

California Cancer Center

Fresno, California, 93720, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Memorial Regional Cancer Center at Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Savannah Hematology Oncology Associates

Savannah, Georgia, 31405, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231-2410, United States

Location

Kansas City Internal Medicine

Kansas City, Missouri, 64132, United States

Location

Lourdes Regional Cancer Center

Binghamton, New York, 13905, United States

Location

Saint Vincent Catholic Medical Center of New York

New York, New York, 10011, United States

Location

Presbyterian Healthcare

Charlotte, North Carolina, 28233-3549, United States

Location

Akron City Hospital

Akron, Ohio, 44309, United States

Location

Medical Oncology Hematology Associates, Inc.

Dayton, Ohio, 45409, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

Cancer Care Institute of South Texas

San Antonio, Texas, 78229, United States

Location

Danville Hematology and Oncology, Inc.

Danville, Virginia, 24541, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Nasopharyngeal Neoplasms; Mouth Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Arlene A. Forastiere, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 22, 2004
• Study Start: September 1, 1997
• Last Updated: July 24, 2008

Record last verified: 2001-11

Locations

US (20)