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Head and Neck CancerPhase 2NCT00101075

Title XELOX FOR SALIVARY GLAND CANCERS

A Phase 2 study testing Capecitabine and Oxaliplatin in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute 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

The goal of this clinical research study is to find out how effective oxaliplatin and capecitabine are against advanced cancer of the salivary gland. The safety of this treatment as well as how long the cancer responds or stays in a stable state due to the treatment will also be studied. 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?
Capecitabine and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Oct 2004to Mar 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

  • Histologic diagnosis of any of the following malignancies originating from salivary tissue: adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma, malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated carcinoma, squamous cell carcinoma, adenocarcinoma.
  • Patients must be incurable on the basis of unresectable local or distant disease as determined by the patient's surgeon and not be potentially curable by radiation therapy as determined by a radiation oncologist.
  • Patients may have received radiation to any site with the following caveat: the sites used for evaluation for response are either not previously irradiated or they have shown progression of disease post radiation and there has been a time interval of one month since these sites were radiated.
  • Patients must have an ECOG performance status of less than 3.
  • Patients must have at least uni-dimensionally measurable disease documented within one month of initiation of treatment. Measurement may be by physical exam or radiologically. Attempts should be made to photo document all tumor sites assessed by physical examination with a metric ruler within the photo for measurement confirmation.
  • Patients must be willing and able to go through the process of informed consent.
Show all 19Show fewer
  • Patients must have a life expectancy exceeding 3 months.
  • Patients must be at least 18 years old.
  • Patients must have adequate organ function as defined by the following tests to be performed within 14 days of therapy initiation:
  • Absolute neutrophil count > 1999 cells x 10 6/L
  • Platelet count > 99,999 cells x 10 6/L
  • Hemoglobin >8.5 gm/di or HCT > 25%
  • Serum creatinine < 1.5 x institutional upper limits of normal (ULN) or creatinine clearance measured by 24 hour urine collection as at least 50% of institutional lower limit of normal.
  • Total bilirubin <2 x institutional ULN
  • AST (SGOT) <2 x institutional ULN*
  • * If from documented liver involvement with cancer, may be up to < 5 x institutional ULN Alkaline Phosphatase < 5 x institutional ULN #
  • # If from documented bone or liver involvement with cancer, no upper limit restriction.
  • Subjects (male or female) must agree to use effective methods of birth control while on study.
  • Subjects should be able to tolerate and swallow tablets or undergo GI tube insertion.

Who cannot join

  • Patients must have not received cytotoxic chemotherapy for metastatic salivary gland cancer. Previous immunologic, hormonal, homeopathic, natural, or alternative medicine therapies are acceptable provided treatment ended greater than 28 days prior to protocol therapy. Patients may have received chemotherapy given concomitantly with radiation therapy in an adjuvant setting with curative intent.
  • Patients must not receive any form (including radiotherapeutic, immunologic, hormonal,homeopathic, natural, or alternative medicine) of anti-neoplastic therapy other than XELOX while participating in this study.
  • Patients must not have a history of any invasive neoplasm within three years of trial entry, excepting curatively treated non-melanoma skin cancer and cervical cancer.
  • Pregnant and breast feeding women are not eligible for this study. No pregnancy test is required. Women of childbearing potential must be counseled on the use of effective birth control prior to participation in this study.
  • Patients with significant active illness (e.g. congestive heart failure, COPD, uncontrolled diabetes) are not eligible for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Patients With Locally Advanced, Incurable, Salivary Gland Cancers

The goal of this clinical research study is to find out how effective oxaliplatin and capecitabine are against advanced cancer of the salivary gland. The safety of this treatment as well as how long the cancer responds or stays in a stable state due to the treatment will also be studied.

Read the detailed description

This is a study of two investigational agents called oxaliplatin and capecitabine.

Investigational agents have not received Food and Drug Administration (FDA) approval for the way they are being used in this study. This means an investigation drug is still under study to determine what a safe dose is, what the side effects are and whether or not it is effective in the disease or condition being studied.

Oxaliplatin and capecitabine are chemotherapy agents that have been approved by the FDA for use in other cancers.

Keywords
high-grade salivary gland mucoepidermoid carcinoma, low-grade salivary gland mucoepidermoid carcinoma, salivary gland acinic cell tumor, salivary gland adenocarcinoma, salivary gland adenoid cystic carcinoma, salivary gland malignant mixed cell type tumor, salivary gland poorly differentiated carcinoma, salivary gland squamous cell carcinoma, recurrent salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer
Medical subject headings
Head and Neck Neoplasms, Salivary Gland Neoplasms

What participants receive

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

Study groups in NCT00101075
Study groupRoleWhat they receive
XELOXExperimental* Oxaliplatin 130 mg/m2 day 1 every 3 weeks * Capecitabine 1700 mg/m2/day days 1-14 every 3 weeks. -- Patients will be evaluated for response at the end of cycle 2 and at the end of every even cycle thereafter.
Receives: Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

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

  1. Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment

    Measured: Every 2 Cycles

Secondary outcomes (3)

  1. Progression-free survival as assessed by RECIST criteria at every 2 courses of treatment

    Measured: Every 2 Cycles

  2. Toxicity as assessed by CTCAE weekly

    Measured: Weekly

  3. Expression of signal transduction and cell cycle regulatory proteins as assessed by biopsy at baseline and day 3

    Measured: Baseline andDay 3

Timeline

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

  1. First posted10 Jan 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionMar 2007
  4. Study completionMar 2008

Why it stopped: Slow Accrual

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101075
Sponsor's protocol ID
04-149
Other IDs
P30CA006516, SANOFI-DFCI-04149
Status last verified
Feb 2017
First submitted
7 Jan 2005
Last updated
27 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine and Oxaliplatin in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute 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 19 inclusion and 5 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 27 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?

The study was stopped early (reason given: Slow Accrual). 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.

What does the primary outcome measure?

Tumor response rate as assessed by RECIST criteria at every 2 courses of treatment (time frame: Every 2 Cycles). 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 NCT00101075.

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 27 Feb 2017.

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