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Head and Neck Squamous Cell CarcinomaPhase 2NCT02524275

Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study testing Capecitabine, Docetaxel and Quality-of-Life Assessment in people with Head and Neck Squamous Cell Carcinoma, run by University of Nebraska at 3 sites 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

This phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Capecitabine, Docetaxel and Quality-of-Life Assessment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
30 Mar 2015to 28 Oct 2021
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 proven squamous cell carcinoma of the head and neck with measurable disease that is either recurrent after attempted cure with surgery and/or radiation therapy or newly diagnosed disease with distant metastases or incurable at diagnosis
  • Performance status: Karnofsky score >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
  • Age 19 years or older (age of consent in Nebraska); age 18 years or older (applicable to states where the age of majority is 18)
  • No prior chemotherapy for metastatic squamous cell carcinoma of the head and neck; subjects who have received chemotherapy as part of a multi-modality curative approach for head and neck cancer will be eligible as long as they have not received either docetaxel or capecitabine (or fluorouracil [5-FU]) as part of that regimen
  • White blood cell (WBC) count >= 3,500/mm^3
  • Platelet count >= 100,000/mm^3
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  • Serum creatinine less than 1.5 times the upper limits of normal
  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 1.5 times the upper limits of normal
  • Serum alkaline phosphatase less than 2.5 times the upper limits of normal
  • Serum total bilirubin is less than or equal to the upper limits of normal
  • Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless subject is receiving anticoagulants; if the subject is on anticoagulation therapy, levels should be within therapeutic range
  • Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
  • Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
  • The subject must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

Who cannot join

  • Prior chemotherapy for metastatic squamous cell carcinoma of the head and neck; subjects who have received chemotherapy as part of a multi-modality curative approach for head and neck cancer will be eligible as long as they have not received either docetaxel or capecitabine (or 5-FU) as part of that regimen
  • Allergy to either of the study medications or 5-fluorouracil
  • Simultaneous participation in other therapeutic clinical trials will not be allowed
  • If a subject is receiving allopurinol/cimetidine/antivirals they must be discontinued prior to starting this protocol
  • Prior malignancy, except for adequately treated basal cell or squamous cell carcinoma of the skin, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen (PSA) levels (gonadotropin-releasing hormone [GnRH] analogs or androgen receptor blockers acceptable); or other cancers from which the subject has been disease-free for at least five years
  • Uncontrolled intercurrent illnesses including, but not limited to symptomatic congestive heart failure, severe oxygen dependent chronic obstructive pulmonary disease, unstable angina or uncontrolled cardiac arrhythmia that could jeopardize the subject?s ability to receive the chemotherapy described in the protocol safely
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  • Pregnant and nursing women are excluded from this study
  • Inability to co-operate with the study visit schedule and other requirements of the protocol
  • Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator?s opinion, may interfere with protocol adherence or a subject?s ability to give informed consent

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Faith Regional Health Services Carson Cancer Center

    Norfolk, Nebraska, 68701

  • Omaha Veterans Administration Medical Center

    Omaha, Nebraska, 68105

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Phase II Study of Docetaxel and Capecitabine in Advanced Squamous Cell Carcinoma of the Head and Neck

This phase II trial studies the side effects and how well docetaxel and capecitabine work in treating patients with squamous cell (thin, flat cells) carcinoma of the head and neck that has come back or spread to other places in the body. Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate in a phase II study the efficacy (the radiographic assessment of disease status after 2 cycles of therapy) of a combination of docetaxel and capecitabine in subjects with advanced squamous cell carcinoma of the head and neck who are not candidates for surgery or radiation therapy.

II. To evaluate the safety and toxicities of docetaxel and capecitabine in subjects with advanced squamous cell carcinoma of the head and neck.

III. To descriptively examine the effects of the combination of docetaxel and capecitabine on the quality of life of subjects with advanced squamous cell carcinoma of the head and neck.

OUTLINE:

Patients receive docetaxel intravenously (IV) over 1 hour on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then periodically thereafter.

Being tested
Capecitabine, Docetaxel, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
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.

  • CapecitabineDrug

    Also called Ro 09-1978/000, Xeloda

    Given PO

  • DocetaxelDrug

    Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT02524275
Study groupRoleWhat they receive
Treatment (docetaxel, capecitabine)ExperimentalPatients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Capecitabine; Drug: Docetaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

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

  1. Overall Response Rate of Complete or Partial Response

    The response rates of complete or partial response rate as defined by the Response Evaluation Criteria for Solid Tumors at 15 weeks of a chemotherapy regimen involving docetaxel and capecitabine as front line therapy at 95% confidence interval. Complete Response (CR): the disappearance of all target lesions Partial Response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter

    Measured: At 15 weeks

Secondary outcomes (2)

  1. Progression-free Survival

    The Kaplan-Meier method will be used to estimate time to event distributions for progression-free survival. Progression-free survival will be defined as from the first date of therapy until the first notation of clinical progression, relapse or death from any cause.

    Measured: First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 5 years

  2. Survival

    The Kaplan-Meier method will be used to estimate time to event distributions for survival. Survival will be defined as from the first date of therapy until the date of death from any cause.

    Measured: First date of therapy until the date of death from any cause, assessed up to 5 years

Timeline

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

  1. First posted14 Aug 2015 (estimated)
  2. Study start30 Mar 2015
  3. Primary completion28 Oct 2021
  4. Study completion28 Oct 2021

Why it stopped: low enrollment

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02524275
Sponsor's protocol ID
0762-14-FB
Other IDs
NCI-2015-00587
Status last verified
Aug 2023
First submitted
12 Aug 2015
Last updated
8 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Docetaxel and Quality-of-Life Assessment in people with Head and Neck Squamous Cell Carcinoma, run by University of Nebraska at 3 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 14 inclusion and 9 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: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 1 Sep 2022). 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?

Overall Response Rate of Complete or Partial Response (time frame: At 15 weeks). 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 NCT02524275.

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 8 Sep 2023.

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