Drug/Agent Toxicity by Tissue/OrganPhase 1/2NCT00003251
Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer
A Phase 1/2 study testing amifostine trihydrate, cisplatin and paclitaxel in people with Drug/Agent Toxicity by Tissue/Organ and Head and Neck Cancer, run by University of Illinois Chicago at 1 site 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. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Radiation Toxicity
- What is being tested?
- amifostine trihydrate, cisplatin and paclitaxel
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1997to not given
- Phase
- Phase 1/2
- 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 or cytologically documented metastatic or previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head and neck Unresectable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 2.5 times normal SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Other: No other significant infection No other medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 months since prior radiotherapy (patients with recurrent disease) to head and neck region Surgery: Not speciified Other: At least 24 hours since antihypertensive medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
About this study
Official title: A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin, paclitaxel, and radiation therapy in treating patients who have advanced unresectable head and neck cancer.
Read the detailed description
OBJECTIVES: I. Assess the efficacy and role of amifostine as a cytoprotection agent with concurrent chemoradiotherapy in advanced, previously irradiated or metastatic head and neck cancer. II. Determine the toxicity and response to cisplatin, paclitaxel and radiation therapy in these patients. III. Determine the toxicity of amifostine in these patients.
OUTLINE: This is an open label study. Patients receive paclitaxel by continuous infusion on days 0-3. Amifostine IV is administered over 5 minutes on days 1-5. Radiation therapy is administered once daily on days 1-5. Cisplatin IV is administered on day 5. Patients receive no treatment on days 6-13. Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity. Patients are followed monthly during the first year, every 2 months during the second year, then every 3 months thereafter.
PROJECTED ACCRUAL: This study will accrue 16-46 patients.
- Being tested
- amifostine trihydrate, cisplatin, paclitaxel, radiation therapy
- Keywords
- stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer, recurrent nasopharyngeal cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, high-grade salivary gland mucoepidermoid carcinoma, stage III lip and oral cavity cancer, stage IV lip and oral cavity cancer, recurrent lip and oral cavity cancer, stage III hypopharyngeal cancer, stage IV hypopharyngeal cancer, recurrent hypopharyngeal cancer, stage III laryngeal cancer, stage IV laryngeal cancer, recurrent laryngeal cancer, stage III paranasal sinus and nasal cavity cancer, stage IV paranasal sinus and nasal cavity cancer, recurrent paranasal sinus and nasal cavity cancer
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Head and Neck Neoplasms, Radiation Injuries, Nasopharyngeal Neoplasms, Salivary Gland Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amifostine trihydrateDrug
cisplatinDrug
paclitaxelDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2004 (estimated)
- Study startDec 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug/Agent Toxicity by Tissue/OrganStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Supportive care
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Investigators
- Fred R. Rosen, MD, Study chair, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003251
- Sponsor's protocol ID
- CDR0000066133
- Other IDs
- UIC-H-97-783, ALZA-UIC-H-97-783, NCI-V98-1389
- Status last verified
- Jun 2000
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00003251
- Acronym / sponsor ID
- CDR0000066133
- Keywords
- stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer, recurrent nasopharyngeal cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, salivary gland squamous cell carcinoma, high-grade salivary gland mucoepidermoid carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Dec 1997
- First posted
- 13 Aug 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. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin, paclitaxel, and radiation therapy in treating patients who have advanced unresectable head and neck cancer.
Detailed description
OBJECTIVES: I. Assess the efficacy and role of amifostine as a cytoprotection agent with concurrent chemoradiotherapy in advanced, previously irradiated or metastatic head and neck cancer. II. Determine the toxicity and response to cisplatin, paclitaxel and radiation therapy in these patients. III. Determine the toxicity of amifostine in these patients.
OUTLINE: This is an open label study. Patients receive paclitaxel by continuous infusion on days 0-3. Amifostine IV is administered over 5 minutes on days 1-5. Radiation therapy is administered once daily on days 1-5. Cisplatin IV is administered on day 5. Patients receive no treatment on days 6-13. Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity. Patients are followed monthly during the first year, every 2 months during the second year, then every 3 months thereafter.
PROJECTED ACCRUAL: This study will accrue 16-46 patients.
Study design
- Primary purpose
- Supportive care
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 |
|---|---|---|
| amifostine trihydrate | Drug | – |
| cisplatin | Drug | – |
| paclitaxel | Drug | – |
| radiation therapy | Radiation | – |
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 4 Dec 2013.
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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.
Fred R. Rosen, MD study chair
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing amifostine trihydrate, cisplatin and paclitaxel in people with Drug/Agent Toxicity by Tissue/Organ and Head and Neck Cancer, run by University of Illinois Chicago at 1 site 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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 4 Dec 2013.