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Head and Neck CancerPhase 1NCT00006107

Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

A Phase 1 study testing Taxotere, Surgery and radiation therapy in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 2 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

Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer. 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?
Taxotere, Surgery and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesUnited States
Study dates
14 Jul 2000to 3 Jul 2004
Phase
Phase 1
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

  • Pathology:
  • -- Histologic documentation of squamous cell carcinoma of the head and neck or its variants (lymphoepithelioma, undifferentiated epidermoid carcinoma, etc.).
  • Stage:
  • -- Patients will be entered on this protocol after initial induction therapy, if, prior to the induction regimen, they were previously untreated Stage III or IV (MO) SCCHN. Evaluable disease during induction therapy is required.
  • Required Prior Therapy: Patients entered on this protocol will have received platinum/FUra based induction chemotherapy. They may have received a taxane as part of this plan.
  • Patients treated with induction are eligible provided that they receive no more than 3 cycles of chemotherapy, but at least one cycle of chemotherapy, and are less then 7 weeks from the start of last cycle of induction therapy.
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  • Other Malignancies:
  • Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥2 years prior to study entry.
  • Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
  • Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
  • Other Prior Therapy:
  • Patients treated with induction therapy
  • Hormonally treated patients are eligible.
  • Performance: Patients must meet the following performance criteria:
  • Performance status: ≤2 (ECOG) Complete recovery from previous diagnostic or therapeutic procedures is required.
  • Nutritional Status: Adequate and nutritionally balanced enteral intake ≥ 1,800 kcal/day).
  • A PEG is required prior to initiation of radiation.
  • Age: ≥18 years
  • Life Expectancy: Longer than 3 months.
  • Women of child bearing potential must not be pregnant by history or lactating at the time of entry on this protocol and men and women of child bearing potential must be requested to use an accepted and effective method of birth control during therapy.
  • Organ Function: Biochemical and hematological parameters (obtained within 2 weeks of study entry) as follows:
  • Hepatic: SGOT < 1.5 x ULN and Alkaline Phosphatase < 2.5 x ULN for entry. Total Bilirubin = WNL and SGOT must be ≤ 2 x ULN as an isolated value. SGPT ≤ 2.5 x ULN
  • Hematologic: WBC ≥ 3,000/mm3 or a normal absolute neutrophil count (ANC) ≥ 1000; Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 10 gm/d1 (transfusion to bring the hemoglobin to or above this level is permitted if clinically indicated, however, transfusions should not be used solely in order to meet eligibility criteria).
  • Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2.
  • Other: Lack of other serious illness or medical condition
  • Informed consent:
  • -- Patients must give written informed consent.
  • Follow-up:
  • All patients must be available for monthly evaluation and re-staging by the physicians from the Head and Neck Cancer Clinic while on therapy.

Who cannot join

  • Pathology:
  • -- Patients with previous head and neck cancer are ineligible, except patients who were treated with surgery as the sole modality ≥ 2 years prior to study entry.
  • Other Malignancies:
  • Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
  • Patients with any non-SCCHN malignancy within 3 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are ineligible.
  • Other Prior Therapy:
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  • Patients who were previously treated with radiotherapy for SCCHN are not eligible.
  • Patients treated with any form of prior chemotherapy, other than induction therapy within the last 5 years are not eligible
  • Performance:
  • Nutritional Status: Patients requiring intravenous alimentation as primary source of calories are excluded from this study.
  • Patients with persistent diarrhea are ineligible.
  • Organ Function:
  • -- Neurologic: Peripheral neuropathy of any etiology must not exceed grade 2.
  • -- Cardiovascular/Pulmonary: No acute cardiac dysrhythmias or unstable cardiac condition such as angina.
  • Follow-up:
  • Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 will be excluded.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)

Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy.
  • Determine the toxicity of this treatment regimen in this patient population.
  • Determine the efficacy of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of docetaxel.

Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks.

Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy.

Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD.

Patients are followed monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.

Being tested
Taxotere, Surgery, radiation therapy
Keywords
recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms

What participants receive

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

  • TaxotereDrug

    Also called Docetaxel

  • SurgeryProcedure or surgery

  • radiation therapyRadiation

Study groups in NCT00006107
Study groupRoleWhat they receive
TaxotereExperimental* Taxotere: (1 hour infusion once a week for four weeks) * Radiation Therapy (5 days/week for 6-7 weeks) * Surgery (if required) 14 -12 weeks after radiotherapy * Follow-up
Receives: Drug: Taxotere; Procedure: Surgery; Radiation: radiation therapy

What is being measured

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

  1. MTD of Taxotere

    Measured: 8 Weeks

  2. Dose Limiting Toxicity

    Measured: 8 Weeks

Secondary outcomes (2)

  1. Overall Response Rate

    Measured: 4-12 weeks post chemo/radiation therapy

  2. Tumor Resistance Predictors

    Tumor Biopsies and tissues

    Measured: Up to 1 year post chemo/radiation therapy

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study start14 Jul 2000
  3. Primary completion17 Jul 2003
  4. Study completion3 Jul 2004

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006107
Sponsor's protocol ID
99-274
Other IDs
P30CA006516, NCI-G00-1833
Status last verified
Jun 2017
First submitted
3 Aug 2000
Last updated
16 Jun 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Taxotere, Surgery and radiation therapy in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 2 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 29 inclusion and 16 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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.

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?

MTD of Taxotere (time frame: 8 Weeks). The study lists 2 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 NCT00006107.

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 16 Jun 2017.

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