Nasopharyngeal CancerPhase 2NCT02608073
A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer
A Phase 2 study testing Capecitabine and Cisplatin in people with Nasopharyngeal Cancer, run by Hoffmann-La Roche at 9 sites in 5 countries.
Trial summary
This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- Capecitabine and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Nov 2004to Nov 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 to 75 years of age
- Histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated
- Ability to swallow and retain oral medication
Who cannot join
- Previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment
- Clinically significant cardiac disease
- History of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix
- Radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Taiwan3 sites
Study site
Kueishan, 333
Study site
Taipei, 00112
Study site
Taipei, 106
About this study
Official title: A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.
- Conditions
- Nasopharyngeal Cancer
- Being tested
- Capecitabine, Cisplatin
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Participants will receive oral capecitabine, 1000 mg/m^2 BID on Days 1 to 14 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
CisplatinDrug
Participants will receive cisplatin, 100 mg/m^2 via IV infusion on Day 1 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine + Cisplatin | Experimental | Participants with metastatic nasopharyngeal cancer will receive combination treatment with capecitabine (1000 milligrams per meter square [mg/m^2] tablets twice daily [BID] orally) and cisplatin (100 mg/m^2/day intravenous [IV] infusion) for up to 8 cycles. Receives: Drug: Capecitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: up to 28 days after the last intake of study treatment (up to approximately 5 years)
Secondary outcomes (7)
Overall survival
Measured: Up to approximately 18 months
Time to disease progression
Measured: Up to approximately 18 months
Duration of response
Measured: Up to approximately 18 months
Complete response rate
Measured: Up to approximately 18 months
Incidence of adverse events
Measured: Up to approximately 7 months
Quality of life according to Visual Analog Scale (VAS) score
Measured: Up to approximately 6 months
Treatment convenience/satisfaction according to VAS score
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2004
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608073
- Sponsor's protocol ID
- ML18123
- Status last verified
- Mar 2016
- First submitted
- 16 Nov 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02608073
- Acronym / sponsor ID
- ML18123
- Conditions
- Nasopharyngeal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine + Cisplatin | Experimental | Drug: Capecitabine, Drug: CisplatinParticipants with metastatic nasopharyngeal cancer will receive combination treatment with capecitabine (1000 milligrams per meter square [mg/m^2] tablets twice daily [BID] orally) and cisplatin (100 mg/m^2/day intravenous [IV] infusion) for up to 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 to 75 years of age
- Histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated
- Ability to swallow and retain oral medication
Key exclusion criteria (4 listed)
- Previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment
- Clinically significant cardiac disease
- History of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix
- Radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: XelodaParticipants will receive oral capecitabine, 1000 mg/m^2 BID on Days 1 to 14 of each 21-day cycle, for up to 8 treatment cycles (24 weeks). | Drug | Capecitabine + Cisplatin |
| CisplatinParticipants will receive cisplatin, 100 mg/m^2 via IV infusion on Day 1 of each 21-day cycle, for up to 8 treatment cycles (24 weeks). | Drug | Capecitabine + Cisplatin |
Primary outcome
Overall response rate
Time frame: up to 28 days after the last intake of study treatment (up to approximately 5 years)
7 secondary outcomes
Overall survival
Time frame: Up to approximately 18 months
Time to disease progression
Time frame: Up to approximately 18 months
Duration of response
Time frame: Up to approximately 18 months
Complete response rate
Time frame: Up to approximately 18 months
Incidence of adverse events
Time frame: Up to approximately 7 months
Quality of life according to Visual Analog Scale (VAS) score
Time frame: Up to approximately 6 months
Treatment convenience/satisfaction according to VAS score
Time frame: Up to approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and Cisplatin in people with Nasopharyngeal Cancer, run by Hoffmann-La Roche at 9 sites in 5 countries.
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 3 inclusion and 4 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 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan, Hong Kong, Thailand, Indonesia, Malaysia. 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?
Overall response rate (time frame: up to 28 days after the last intake of study treatment (up to approximately 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2016.