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Head and Neck CancerPhase 2NCT00095901

Capecitabine For Nasopharyngeal Cancer

A Phase 2 study testing Capecitabine in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 3 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 study plans to examine the effects of Capecitabine administered as an oral chemotherapy drug in participants with nasopharyngeal cancer. Capecitabine is an oral prodrug. A "prodrug" is a drug that is converted within the body into its active form that has medical effects. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
3 sitesUnited States
Study dates
Jun 2004to May 2007
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

  • To be eligible for inclusion, each patient must fulfill each of the following criteria:
  • Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (see Appendix C).
  • Histologically confirmed nasopharyngeal carcinoma, WHO types I, II or III, with recurrent locoregional and/or metastatic disease. Primary cancers of the nasal cavity or paranasal sinuses, sinonasal neuroendocrine carcinomas or primary malignancies of the salivary gland will NOT be eligible.
  • Have received at least one, but no more than 2, prior chemotherapy regimens for recurrent and/or metastatic disease. Patients with recurrent locoregional and/or metastatic NPC who are unable to tolerate a platinum-based chemotherapy due to previous treatment with a platinum or a condition that precludes their use will also be eligible.
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  • Have tumor tissue available for EBER analysis, if not already done.
  • Have at least one measurable lesion according to the RECIST criteria (see Appendix B) which has not been irradiated within 6 months of enrollment. Pleural effusion and bone metastases are not considered measurable. Minimum indicator lesion size: ≥ 10 mm measured by spiral CT or ≥ 20 mm measured by conventional techniques.
  • Have a negative serum or urine pregnancy test within 7 days prior to registration in female patients of childbearing potential.

Who cannot join

  • Patients who fulfill any of the following criteria will be excluded:
  • Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Women or men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • Life expectancy <3 months.
  • Serious, uncontrolled, concurrent infection(s).
  • Prior fluoropyrimidine therapy within 6 months of enrollment. Subjects with previous 5-FU or other fluoropyrimidine treatment are eligible, if ≥ 6 months has elapsed since this previous therapy.
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known extreme sensitivity to 5-FU.
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  • Completion of previous chemotherapy regimen < 4 weeks prior to the start of study treatment, or with related toxicities unresolved prior to the start of study treatment.
  • Previous radiotherapy < 4 weeks prior to the start of study treatment.
  • Other malignancy within the last five years, except non-melanoma skin and in-situ cervical cancer.
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
  • Evidence of central nervous system (CNS) metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
  • Major surgery within 4 weeks of the start of study treatment, without complete recovery.
  • Malabsorption syndrome of the upper gastrointestinal tract.
  • Any of the following laboratory values:
  • Abnormal hematologic values (neutrophils < 1.5 x 10 9/L, platelet count < 100 x 10 9/L)
  • Impaired renal function (estimated creatinine clearance <30 ml/min as calculated with Cockroft-Gault equation or serum creatinine > 1.5 x upper normal limit).
  • Note: In patients with moderate renal impairment (estimated creatinine clearance 30-50 mL/min) at baseline, a dose reduction to 75% of the capecitabine starting dose is recommended.
  • Serum bilirubin > 1.5 x upper normal limit.
  • ALT, AST > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases).
  • Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases or > 10 x upper normal limit in the case of bone disease).
  • Unwillingness to give written informed consent.
  • Unwillingness to participate or inability to comply with the protocol for the duration of the study.
  • Other serious uncontrolled medical conditions that the investigator feels might compromise study participation

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma

This study plans to examine the effects of Capecitabine administered as an oral chemotherapy drug in participants with nasopharyngeal cancer.

Capecitabine is an oral prodrug. A "prodrug" is a drug that is converted within the body into its active form that has medical effects. Capecitabine is a prodrug of 5-fluorouracil (5-FU), which is a chemotherapy agent frequently used to treat head and neck cancers. Capecitabine is absorbed through the gastrointestinal tract and is converted to 5-FU. Capecitabine (Xeloda9) has been tested in subjects with colorectal and breast cancers, and shown to be effective in those cancers. Likewise, 5-FU has shown benefit when administered as a continuous infusion for those with nasopharyngeal cancers. Since Capecitabine is a prodrug of 5-FU, it is possible that similar results will be achieved.

Read more

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have locally recurrent or metastatic nasopharyngeal cancer.

Read the detailed description

This is a nonrandomized, multicenter study.

  • Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days.
Being tested
Capecitabine
Keywords
recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

Study groups in NCT00095901
Study groupRoleWhat they receive
CapecitabineExperimentalCapecitabine (Xeloda 4:14. ) 150 mg and 500 mg tablets. Capecitabine will be administered at a dose of 1000 mg/m2 twice daily, for a total daily dose of 2000 mg/m 2. Capecitabine will administered P.O. or per G-tube B.I.D. for 14 days, followed by a one-week rest period in 3-week cycles.
Receives: Drug: Capecitabine

What is being measured

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

  1. Rate of Response

    Tumor response rate based on tumor measurement (according to the nasT criteria). Response Evaluation Criteria in Solid Tumors (RECIST).

    Measured: 4 weeks

Secondary outcomes (5)

  1. Correlation of Epstein-Barr virus (EBV) with response as assessed by a two-sample t-test with arcsin approximation

    Measured: Baseline and every 2 cycles

  2. Correlation of EBV status to thymidine phosphorylase expression as assessed by Fischer's exact test

    Measured: Basleine and every 2 cycles

  3. Correlation of response to thymidine phosphorylase expression as assessed by Fischer's exact test

    Measured: Baseline and every 2 cycles

  4. Rate of Progression Free Survival

    Measured: Study Day 1 to the date of first known disease progression, or the date of death if the patient

  5. Rate of Overall Survival

    Measured: Study Day 1 to the date of death or the last date patient was known to be alive

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 startJun 2004
  3. Primary completionMay 2007
  4. Study completionMay 2007

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095901
Sponsor's protocol ID
03-384
Other IDs
P30CA006516
Status last verified
Mar 2018
First submitted
9 Nov 2004
Last updated
29 Mar 2018
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 in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute 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 9 inclusion and 24 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 29 Mar 2018. 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?

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 Response (time frame: 4 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 NCT00095901.

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 29 Mar 2018.

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