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Chemotherapeutic Agent ToxicityPhase 2NCT00095927

Randomized Amifostine For SCCHN

A Phase 2 study testing Amifostine, Carboplatin and Paclitaxel in people with Chemotherapeutic Agent Toxicity and Head and Neck Cancer, run by Dana-Farber Cancer Institute at 9 sites 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

This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Amifostine, Carboplatin and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
9 sitesUnited States
Study dates
May 2003to Jun 2008
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

Who may be able to join

  • Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated.
  • Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary SCC in the neck will also be eligible.
  • Stage 2, 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound or CT (in case of liver function test abnormalities); bone scan in case of local symptoms.
  • At least one uni- or bidimensionally measurable lesion at the start of all therapy (induction therapy ag well as chemoradiation).
  • No previous head and neck radiotherapy and no previous curative surgery for SCCHN (other than biopsy) are allowed at time of study entry.
  • Age ≥ 18 years.
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  • WHO performance status of 0 or 1 (section 13, Appendix I)
  • No active alcohol addiction (as assessed by medical caregiver).
  • Life expectancy ≥ 12 weeks.
  • Signed informed consent prior to beginning protocol specific procedures.
  • Adequate bone marrow, hepatic and renal functions as evidenced by the following:
  • Hematology:
  • neutrophil count ≥ 2.0 x 10 9/1.
  • platelet count ≥ 100 x 10 9/1.
  • hemoglobin ≥ 10 g/dl.
  • Hepatic function:
  • total bilinthin WNL.
  • ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x 1JLN.
  • alkaline phosphatase ≤ 5 x ULN.
  • patients with ASAT or ALAT > 1.5 x ULN associated with alkaline phosphatase > 2.5
  • x ULN are not eligible for the study.
  • Renal function: the creatinine clearance ≥ 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows:
  • Weight(kg) x (140 - age)/K x serum creatinine
  • serum creatinine in mg/dL
  • K: 72 in man
  • K: 85 in woman
  • serum creatinine in µmon/L
  • K: 0.814 in man
  • K: 0.96 in woman
  • Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centers
  • Previous chemotherapy is permitted, provided that it is in induction form before starting radiation therapy and that it is being used to treat head and neck cancers.

Who cannot join

  • Pregnant or lactating women, or women of childbearing potential not using adequate contraception.
  • Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 3 years.
  • Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria.
  • Other serious illnesses or medical conditions including but not limited to:
  • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
  • History of significant neurologic or psychiatric disorders including dementia or seizures.
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  • Active uncontrolled infection.
  • Active peptic ulcer.
  • Hypercalcemia.
  • Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
  • Patients requiring intravenous alimentation.
  • Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry (unless purposeful)
  • Concurrent treatment with any other anticancer therapy.
  • Participation in an investigational trial within 30 days of study entry.
  • Previous treatment with any biologic therapy is not permitted.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bethke Cancer Center at Emerson Hospital

    Concord, Massachusetts, 01742

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • Wentworth Douglass Hospital

    Dover, New Hampshire, 03820

  • Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Goodall Hospital

    Sanford, Maine, 04703

Other trials in United States

About this study

Official title: Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck

This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.

Read the detailed description

Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form.

The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.

Being tested
Amifostine, Carboplatin, Paclitaxel, radiation
Keywords
radiation toxicity, chemotherapeutic agent toxicity, mucositis, xerostomia, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, untreated metastatic squamous neck cancer with occult primary
Medical subject headings
Head and Neck Neoplasms, Mucositis, Radiation Injuries, Xerostomia, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • AmifostineDrug

    Also called Ethyo

    Given subcutaneously

  • CarboplatinDrug

    Also called Paraplatin

    Given IV

  • PaclitaxelDrug

    Also called Taxol, Onxal

    Given IV

  • radiationRadiation

    Given once daily for 4 weeks and then twice daily for 2 weeks.

Study groups in NCT00095927
Study groupRoleWhat they receive
Arm A AmifostineActive comparatorPatients with newly diagnosed, locally advanced stage ill or IV SCCHN received; * 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system). * Subcutaneous daily amifostine at a dose of 500 mg
Receives: Drug: Amifostine; Drug: Carboplatin; Drug: Paclitaxel; Radiation: radiation
Arm B No-AmifostineExperimentalPatients with newly diagnosed, locally advanced stage ill or IV SCCHN - 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: radiation

What is being measured

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

  1. Rate of local/regional control (LRC) 1 year after beginning treatment

    Measured: One year after beginning of treatment

  2. Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months

    Measured: 3, 6 Months

  3. Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy

    Measured: End of Radiotherapy

  4. Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment

    Measured: 8,12, 24 and 52 weeks

Secondary outcomes (6)

  1. Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment

    Measured: 8, 12, 24, and 52 weeks

  2. Proportion of patients with PEG dependency

    Measured: 3, 6, and 12 months after completion of study treatment

  3. Time to disease progression

    Kaplan and Meier

    Measured: baseline to disease progression

  4. Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey

    Measured: baseline, 8, 12, 24, and 52 weeks after completion of study treatment

  5. LRC and overall survival at 2 years after completion of study treatment

    Measured: 2 Years after completion of study treatment

  6. Swallowing function

    Measured: 2 years Post treatment

Timeline

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

  1. First posted9 Nov 2004 (estimated)
  2. Study startMay 2003
  3. Primary completionJun 2007
  4. Study completionJun 2008

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095927
Sponsor's protocol ID
03018
Other IDs
P30CA006516
Status last verified
Jan 2017
First submitted
9 Nov 2004
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Haddad R, Sonis S, Posner M, Wirth L, Costello R, Braschayko P, Allen A, Mahadevan A, Flynn J, Burke E, Li Y, Tishler RB. Randomized phase 2 study of concomitant chemoradiotherapy using weekly carboplatin/paclitaxel with or without daily subcutaneous amifostine in patients with locally advanced head and neck cancer. Cancer. 2009 Oct 1;115(19):4514-23. doi: 10.1002/cncr.24525.

    PubMed 19634161

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amifostine, Carboplatin and Paclitaxel in people with Chemotherapeutic Agent Toxicity and Head and Neck Cancer, run by Dana-Farber Cancer Institute at 9 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?

The sponsor lists 31 inclusion and 15 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

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.

What does the primary outcome measure?

Rate of local/regional control (LRC) 1 year after beginning treatment (time frame: One year after beginning of treatment). The study lists 4 primary outcomes in all. 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 NCT00095927, which also lists 1 linked publication.

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 Jan 2017.

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