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Head and Neck CancerPhase 2NCT00270790

EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)

A Phase 2 study testing Amifostine, Carboplatin and Taxol in people with Head and Neck Cancer, run by Mohan Suntharalingam at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose of this study: There is some evidence that the best treatment for head and neck cancer involves a combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses special medications. 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?
Amifostine, Carboplatin and Taxol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
May 2002to Feb 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites. The following TNM stages by sites will be eligible.
  • Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses: T4 N0-3, A,B,C T3 N1-3 A,B,C any T, N3 A,B,C Unknown primary: Tx, N3 A,B,C Note: Only clearly unresectable T4 N0 lesions are eligible for study provided the reasons for unresectability are due to extensive anatomic involvement and are outlined by the surgeon.
  • Karnofsky performance status of 70% or better at screen and on first day of treatment.
  • Patients with loco-regional recurrences from any site with no prior radiation therapy and not amenable for salvage surgery are eligible for study.
  • No evidence of distant metastatic disease.
  • No previous radiation therapy
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  • No previous chemotherapy.
  • Adequate renal \& bone marrow function determined by the following laboratory parameters.
  • WBC 3500/ul or higher Platelet count 100.000/ul or higher Hemoglobin 9.0 g/dl or higher BUN 25 mg/dl or less, and Screatinine 2.0 mg/dl or less Total bilirubin less than 2.0 mg/dl, AST/ALT less than 3 times the ULN Creatinine Clearance 50 cc/min or higher
  • Evidence of measurable disease.
  • No evidence of concomitant malignancy except for non-melanomatous skin cancer (controlled or controllable) or carcinoma in situ of the cervix.
  • Signed informed consent.
  • No concomitant life threatening or uncontrolled serious medical illness such as end stage congestive heart failure cardiac arrythmia, liver disease and organic brain syndrome.
  • Age 18 years or older.

Who cannot join

  • Preexisting clinically significant neuropathy.
  • Patients currently taking antiarrhythmic medications are excluded.
  • History of poorly-controlled hypertension, angina, arrhythmias, or a history within the past 6 months of myocardial infarction or acute congestive heart failure.
  • Requirement for concurrent use of pilocarpine.
  • Treatment with any investigational drugs within 4 weeks of study entry.
  • Pregnant or lactating females or females of child bearing potential not employing adequate contraception.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A SINGLE SITE EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CONCURRENT CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH ADVANCED LOCOREGIONAL SQUAMOUS CELL CARCINOMAS OF THE HEAD AND NECK.

Purpose of this study:

There is some evidence that the best treatment for head and neck cancer involves a combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses special medications. This study uses two chemotherapy drugs (Taxol and Carboplatin), which are FDA approved for treating head and neck cancers. This treatment combination has been associated with difficulty, pain, or a burning sensation upon swallowing (called esophagitis), and decrease in blood cells (cells in the blood which fight against infection). The purpose of this study is to investigate whether the addition of another drug, Amifostine, can reduce the side effects of current combination treatment (radiation and chemotherapy which is standard of care). The addition of Amifostine is the investigational part of the study. The research study is also looking at the side effects of Amifostine and cancer's growth response to this combination treatment.

Read the detailed description

Patients presenting with locally advanced squamous cell carcinomas of head and neck (SCCHN) continue to represent a significant therapeutic challenge. The bulk of tumor burden often proves to be overwhelming for conventional radiotherapy. Attempts to improve upon these poor outcomes have led investigators to explore several new strategies, one such being chemoradiation. One of the trials conducted at the University of Maryland with carboplatin and paclitaxel with daily radiation showed 82% CR at the primary site. But the most commonly encountered grade 3 toxicities were mucositis (70%), leukopenia (30%) and 3% grade 4 leukopenia. Amifostine: An organic thiophosphate is radioprotective and has shown to protect experimental animals from lethal doses of radiation. Clinical trials have demonstrated that amifostine can provide protection against the hematological toxicities and mucositis seen with various chemotherapeutic agents. Theoretically, drug interactions between amifostine and chemotherapeutic agents are not likely to occur, due to amifostine¿s rapid clearance from plasma (90% of the drug is cleared within 6 minutes). A promising venue would be the investigation of amifostine¿s role in reducing the toxicities associated with chemoradiation (which is standard of care of treating squamous cell carcinomas of head and neck).

Principal objectives of the study: Primary: To evaluate whether the addition of the radioprotector amifostine can reduce the incidence and severity of mucositis and hematological toxicities caused by chemoradiation. Secondary: 1.To determine the toxicities of amifostine given in this setting. 2. To determine the response rate of this regimen in the population.

Being tested
Amifostine, Carboplatin, Taxol, Radiotherapy
Keywords
Head and Neck cancer
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmifostineDrug

    Amifostine will be given at dose of 500 mg IV within one hour before radiation

  • CarboplatinDrug

    Carboplatin for 100 mg/m2 and will be administered after the taxol infusion

  • TaxolDrug

    Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose

  • RadiotherapyDevice

    Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy

Study groups in NCT00270790
Study groupRoleWhat they receive
AMIFOSTINE +CARBOPLATIN, TAXOL +RTExperimentalEVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.
Receives: Drug: Amifostine; Drug: Carboplatin; Drug: Taxol; Device: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine

    Blood work (CMP was collected and evaluated for neutropenia, leukopenia and anemia) is taken prior to chemotherapy administration. The toxicity levels were measured using Common Terminology Criteria for Adverse Events (CTCAE 3.0) and monitored based on the dose of Amifostine given.

    Measured: 3 years

Secondary outcomes (1)

  1. Response Rates Based on the Study Regimen

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2005 (estimated)
  2. Study startMay 2002
  3. Primary completionDec 2005
  4. Study completionFeb 2009

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00270790
Sponsor's protocol ID
HP-00021746
Status last verified
Dec 2016
First submitted
23 Dec 2005
Last updated
1 Feb 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amifostine, Carboplatin and Taxol in people with Head and Neck Cancer, run by Mohan Suntharalingam 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?

The sponsor lists 14 inclusion and 6 exclusion criteria. 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 1 Feb 2017. 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 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?

Yes. Results are posted in the registry (first posted 8 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00270790.

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 1 Feb 2017.

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