Drug/Agent Toxicity by Tissue/OrganPhase 2NCT00025298
Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
A Phase 2 study testing amifostine trihydrate, carboplatin and cisplatin in people with Drug/Agent Toxicity by Tissue/Organ and Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 13 sites in 6 countries.
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 high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications
- What is being tested?
- amifostine trihydrate, carboplatin and cisplatin
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Jul 2001to Oct 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed undifferentiated nasopharyngeal cancer (UNPC)
- Locoregionally advanced disease
- T2b, N1 (greater than 3 cm) or N2
- T3, N1 (greater than 3 cm) or N2
- T4, N1 (greater than 3 cm) or N2
- Any T, N3
- No squamous cell histology
- At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
- No evidence of distant metastases
- No signs or symptoms of CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 15 to 70
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 150,000/mm^3
- Hemoglobin at least 12 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal:
- Creatinine clearance at least 70 mL/min
- Calcium normal
Cardiovascular:
- No hypotension or hypertension requiring therapy
- No prior myocardial infraction
- No pre-existing uncontrolled cardiac disease
- No signs of cardiac failure
- No rhythm disturbances requiring medication
Other:
- No sensory neuropathy grade 2 or greater unless due to cranial nerve
- No uncontrolled infections
- No sensitivity to aminothiol compounds
- No other malignancy within the past 5 years except adequately controlled carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- No psychological, familial, sociological, or geographical condition that would preclude study
- Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- No prior chemotherapy for UNPC
Endocrine therapy:
- No concurrent hormonal therapy except corticosteroids for antiemetic prophylaxis
Radiotherapy:
- No prior radiotherapy for UNPC
Surgery:
- No prior surgery for UNPC except cervical lymphadenectomy
Other:
- At least 1 month since prior investigational agent
- No other concurrent anticancer drugs
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Italy4 sites
Ospedale Santa Croce
Cuneo, 12100
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), 16132
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), 20133
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, 80131
Belgium3 sites
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
U.Z. Gasthuisberg
Leuven, B-3000
France2 sites
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805
Centre Antoine Lacassagne
Nice, 06189
Spain2 sites
Hospital General de Jerez
Jerez de la Frontera, 11407
Hospital Universitario 12 de Octubre
Madrid, 28041
Turkey (Türkiye)1 site
Istanbul University-Institute of Oncology
Istanbul, 34390
United Kingdom1 site
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
About this study
Official title: A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Giving chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin followed by cisplatin plus radiation therapy with or without amifostine in treating patients who have locally advanced cancer of the nasopharynx.
Read the detailed description
OBJECTIVES:
- Compare the overall incidence of grade 3 or 4 mucositis in patients with locally advanced undifferentiated nasopharyngeal cancer treated with paclitaxel and carboplatin followed by cisplatin and radiotherapy with or without amifostine.
- Compare the feasibility and activity of these regimens in these patients.
- Determine the toxicity of paclitaxel and carboplatin in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 vs 2), response to induction chemotherapy (complete vs partial vs stable disease vs not evaluable), and participating center.
Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with a complete or partial response after 2 courses of induction chemotherapy receive 2 additional courses before randomization. Patients with stable disease after 2 courses of induction chemotherapy or who cannot be evaluated after 1 course proceed directly to randomization. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV on days 1, 22, and 43. Patients also undergo radiotherapy daily 5 days a week for 6.5 weeks.
- Arm II:Patients receive amifostine subcutaneously daily. Patients receive chemotherapy and radiotherapy as in arm I.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 41-93 patients will be accrued for this study.
- Conditions
- Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications, Radiation Toxicity
- Being tested
- amifostine trihydrate, carboplatin, cisplatin, paclitaxel, radiation therapy
- Keywords
- stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer, oral complications, drug/agent toxicity by tissue/organ, radiation toxicity
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Head and Neck Neoplasms, Radiation Injuries, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amifostine trihydrateDrug
carboplatinDrug
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 posted27 Jan 2003 (estimated)
- Study startJul 2001
- Primary completionOct 2002
Why it stopped: low accrual
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 European Organisation for Research and Treatment of Cancer - EORTCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Lisa Licitra, MD, Study chair, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025298
- Sponsor's protocol ID
- EORTC-24981
- Other IDs
- EORTC-24981
- Status last verified
- Sep 2012
- First submitted
- 11 Oct 2001
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)
- ClinicalTrials.gov ID
- NCT00025298
- Acronym / sponsor ID
- EORTC-24981
- Conditions
- Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications, Radiation Toxicity
- Keywords
- stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer, oral complications, drug/agent toxicity by tissue/organ, radiation toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jul 2001
- Primary completion
- Oct 2002 (actual)
- First posted
- 27 Jan 2003 (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 high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Giving chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin followed by cisplatin plus radiation therapy with or without amifostine in treating patients who have locally advanced cancer of the nasopharynx.
Detailed description
OBJECTIVES:
- Compare the overall incidence of grade 3 or 4 mucositis in patients with locally advanced undifferentiated nasopharyngeal cancer treated with paclitaxel and carboplatin followed by cisplatin and radiotherapy with or without amifostine.
- Compare the feasibility and activity of these regimens in these patients.
- Determine the toxicity of paclitaxel and carboplatin in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 vs 2), response to induction chemotherapy (complete vs partial vs stable disease vs not evaluable), and participating center.
Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with a complete or partial response after 2 courses of induction chemotherapy receive 2 additional courses before randomization. Patients with stable disease after 2 courses of induction chemotherapy or who cannot be evaluated after 1 course proceed directly to randomization. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV on days 1, 22, and 43. Patients also undergo radiotherapy daily 5 days a week for 6.5 weeks.
- Arm II:Patients receive amifostine subcutaneously daily. Patients receive chemotherapy and radiotherapy as in arm I.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 41-93 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | – |
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| paclitaxel | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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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.
Lisa Licitra, MD study chair
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amifostine trihydrate, carboplatin and cisplatin in people with Drug/Agent Toxicity by Tissue/Organ and Head and Neck Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 13 sites in 6 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: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy, Belgium, France, Spain, Turkey (Türkiye) and 1 more country. 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 was stopped early (reason given: low accrual). 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 Sep 2012.