Head and Neck CancerPhase 2NCT00003327
Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
A Phase 2 study testing paclitaxel in people with Head and Neck Cancer, run by Theradex at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- paclitaxel
- How many people
- 60 participants
- Where
- 20 sitesUnited States
- Study dates
- Sep 1997to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Akron City Hospital
Akron, Ohio, 44309
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Lourdes Regional Cancer Center
Binghamton, New York, 13905
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
Danville Hematology and Oncology, Inc.
Danville, Virginia, 24541
Medical Oncology Hematology Associates, Inc.
Dayton, Ohio, 45409
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
California Cancer Center
Fresno, California, 93720
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, 33021
Kansas City Internal Medicine
Kansas City, Missouri, 64132
Loma Linda University Medical Center
Loma Linda, California, 92354
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Saint Vincent Catholic Medical Center of New York
New York, New York, 10011
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Cancer Care Institute of South Texas
San Antonio, Texas, 78229
Savannah Hematology Oncology Associates
Savannah, Georgia, 31405
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
About this study
Official title: A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer
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.
Read the detailed description
OBJECTIVES: I. Determine the objective response rate of paclitaxel as salvage therapy in patients with recurrent or refractory head and neck cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life in these patients.
OUTLINE: This is an open label, multicenter, nonrandomized study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Patients are followed every 2 months for the first year, then every 4 months until completion of treatment, and then every 3 months until death. Patients complete a quality of life questionnaire prior to each of the first 6 courses, then every 2 courses thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Conditions
- Head and Neck Cancer
- Being tested
- paclitaxel
- 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
- Medical subject headings
- Head and Neck Neoplasms, Nasopharyngeal Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2004 (estimated)
- Study startSep 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theradex
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arlene A. Forastiere, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003327
- Sponsor's protocol ID
- CDR0000066279
- Other IDs
- THERADEX-B97-5250, BMS-TAX/MEN.05, NCI-V98-1415
- Status last verified
- Nov 2001
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Paclitaxel (TAXOL) Administered as a Weekly One Hour Infusion in Previously Treated Patients With Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00003327
- Acronym / sponsor ID
- CDR0000066279
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TheradexIndustry (pharma, biotech, devices)
- Study start
- Sep 1997
- First posted
- 22 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES: I. Determine the objective response rate of paclitaxel as salvage therapy in patients with recurrent or refractory head and neck cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival and quality of life in these patients.
OUTLINE: This is an open label, multicenter, nonrandomized study. Patients receive intravenous paclitaxel over 1 hour weekly. Each course consists of four weeks. Patients receive treatment until disease progression or unacceptable toxic effects are observed. Patients are followed every 2 months for the first year, then every 4 months until completion of treatment, and then every 3 months until death. Patients complete a quality of life questionnaire prior to each of the first 6 courses, then every 2 courses thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene A. Forastiere, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel in people with Head and Neck Cancer, run by Theradex at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2008.