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Head and Neck CancerPhase 2NCT00003777

Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer

A Phase 2 study testing amifostine trihydrate, cisplatin and fluorouracil in people with Head and Neck Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Drugs such as amifostine may prevent the side effects of radiation therapy. 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?
amifostine trihydrate, cisplatin and fluorouracil
Type of treatment
Surgery or procedure
How many people
35 participants
Where
1 siteUnited States
Study dates
Dec 1998to 20 Apr 2001
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 recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field
  • Pathologic stage of recurrence must be rT3-4 and/or rN2-3
  • The following sites are eligible:
  • Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+
  • Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+
  • Any site: Positive margin(s), at least 2 nodes or ECS
  • No primary tumor of the nasopharynx
  • Must be eligible for or have undergone complete resection which leaves behind no gross residual disease
  • Must have prior head and neck irradiation of 45-75 Gy
  • Lifetime spinal cord radiotherapy dose no greater than 50 Gy
  • No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery)
  • No active acute radiation mucositis from previous radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)
  • Platelet count at least 100,000/mm^3

Hepatic:

  • SGOT or SGPT no greater than 3 times upper limit of normal
  • Bilirubin no greater than 2 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled arrhythmias within past 6 months
  • No severe cerebrovascular disease or hypotension not caused by antihypertensive medication

Other:

  • Not pregnant
  • Fertile patients must use effective contraception
  • No allergy to cisplatin, fluorouracil, or amifostine
  • No uncontrolled insulin-dependent diabetes mellitus or other medical condition interfering with wound healing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • Prior radiotherapy treatment records must be available

Surgery:

  • No prior salvage surgery consisting of partial laryngectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

Other trials in United States

About this study

Official title: A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma

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. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.

Read the detailed description

OBJECTIVES:

  • Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer.
  • Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients.

OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32.

Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Being tested
amifostine trihydrate, cisplatin, fluorouracil, surgical procedure, radiation therapy
Keywords
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, stage III oropharyngeal cancer, stage IV oropharyngeal cancer, recurrent oropharyngeal cancer
Medical subject headings
Head and Neck Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Oropharyngeal Neoplasms

What participants receive

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

  • amifostine trihydrateDrug

  • cisplatinDrug

  • fluorouracilDrug

  • surgical procedureProcedure or surgery

  • radiation therapyRadiation

Timeline

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

  1. First posted10 Dec 2003 (estimated)
  2. Study startDec 1998
  3. Primary completionApr 2001
  4. Study completion20 Apr 2001

Why it stopped: PI left institution

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
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003777
Sponsor's protocol ID
CDR0000066906
Other IDs
UPCC-6398, ALZA-98-023-ii, NCI-V99-1518
Status last verified
Jan 2022
First submitted
1 Nov 1999
Last updated
26 Jan 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing amifostine trihydrate, cisplatin and fluorouracil in people with Head and Neck Cancer, run by Abramson Cancer Center at Penn Medicine 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: stopped early, as of the sponsor's last update on 26 Jan 2022. 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?

The study was stopped early (reason given: PI left institution). 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?

On the ClinicalTrials.gov record for NCT00003777.

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 26 Jan 2022.

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