Head and Neck CancerPhase 2NCT00002632
Paclitaxel in Treating Patients With Metastatic or Recurrent Salivary Gland Cancer
A Phase 2 study testing paclitaxel in people with Head and Neck Cancer, run by Eastern Cooperative Oncology Group at 29 sites in 2 countries.
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 metastatic or recurrent salivary gland cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- paclitaxel
- How many people
- 32 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 30 May 1995to May 2002
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, 60611
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
University of Rochester Cancer Center
Rochester, New York, 14642
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Stanford University Medical Center
Stanford, California, 94305-5408
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- paclitaxel
- Keywords
- stage IV salivary gland cancer, recurrent salivary gland cancer, high-grade salivary gland mucoepidermoid carcinoma, salivary gland adenocarcinoma
- Medical subject headings
- Head and Neck Neoplasms, Salivary Gland 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 posted10 Jun 2004 (estimated)
- Study start30 May 1995
- Primary completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Harlan A. Pinto, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002632
- Sponsor's protocol ID
- CDR0000064057
- Other IDs
- E-1394
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 15 Jun 2023
- Results posted
- No
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.
PubMed 16470745Jennings 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 at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II TRIAL OF TAXOL IN ADVANCED OR METASTATIC SALIVARY GLAND MALIGNANCIES
- ClinicalTrials.gov ID
- NCT00002632
- Acronym / sponsor ID
- CDR0000064057
- Conditions
- Head and Neck Cancer
- Keywords
- stage IV salivary gland cancer, recurrent salivary gland cancer, high-grade salivary gland mucoepidermoid carcinoma, salivary gland adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 May 1995 (actual)
- Primary completion
- May 2002 (actual)
- First posted
- 10 Jun 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 metastatic or recurrent salivary gland cancer.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 16470745Gilbert 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.
- Results publicationJennings 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.
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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.
Harlan A. Pinto, MD study chair
Stanford University
29 sites in 2 countries: 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 Eastern Cooperative Oncology Group at 29 sites in 2 countries.
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: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT00002632, which also lists 2 linked publications.
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 15 Jun 2023.