Nasopharyngeal CarcinomaPhase 2NCT00697905
Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Gemcitabine, Carboplatin and Cisplatin in people with Nasopharyngeal Carcinoma, run by Ministry of Health, Malaysia at 11 sites in Malaysia.
Trial summary
The aim of the study is to assess if gemcitabine in combination with carboplatin as 1st line chemotherapy in patients with metastatic or recurrent nasopharyngeal carcinoma has reasonable efficacy and a favourable toxicity profile that warrants further comparative study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Gemcitabine, Carboplatin and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 11 sitesMalaysia
- Study dates
- Jan 2008to May 2011
- 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
- Written informed consent obtained from patient or parents/guardian.
- Subject age greater than or equal to 18 years
- Histologically proven recurrent or metastatic undifferentiated or squamous nasopharyngeal carcinoma, not amenable to local therapy.
- Measurable disease in distant sites and/or loco-regional sites defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as >=10mm with CT scan or MRI. Tumour lesions that are situated in a previously irradiated field are measurable only if the tissue planes are preserved on CT or MRI).
- Prior concurrent chemotherapy and radiation therapy is permitted.
- Primary chemo-radiotherapy must be completed at least 6 months prior to study entry.
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- Life expectancy over 3 months.
- ECOG performance status less than or equal to 2.
- Patients must have normal organ and marrow function as follows:
- White blood cell count : >= 3.0 x 10^9/L
- Absolute neutrophil count : >= 1.5 x 10^9/L
- Platelets : >= 100 x 10^9/L
- Total bilirubin : within normal limits
- AST/ALT/ALP : <= 2.5 x upper limit of normal
- Creatinine clearance or estimated GFR : >=50 mls/min.
Who cannot join
- Patients with any of the following are not eligible for enrollment into the study:
- Pregnant women are excluded from this study because gemcitabine has potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study.
- Women of child-bearing potential and men without an adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Prior use of gemcitabine
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or carboplatin.
- Prior lines of chemotherapy for metastatic NPC
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- Prior radiotherapy to the indicator lesion(s) to be measured in the study.
- Patients receiving any other investigational agents
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Patients with bone-only metastases.
- Clinically significant cardiac disease (e.g. congestive cardiac failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Severe sensorineural hearing loss affecting normal daily activities or requiring the use of hearing aids.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with immune deficiency. They are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- HIV-positive patients receiving combination antiretroviral therapy. There is a possible pharmacokinetic interaction between antiretroviral and gemcitabine or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Malaysia11 sites
Loh Guan Lye Specialist Centre
George Town
Penang General Hospital
George Town
Ipoh Specialist Centre
Ipoh
Johor Specialist Centre
Johor Bahru
NCI Cancer Hospital
Kampung Baharu Nilai
Likas Hospital
Kampung Likas
Sabah Medical Centre
Kota Kinabalu
Tung Shin Hospital
Kuala Lumpur
University Malaya Medical Centre
Kuala Lumpur
Hospital Universiti Sains Malaysia
Kubang Kerian
Normah Medical Specialist Centre
Kuching
About this study
Official title: An Open Labeled, Multicentre, Randomized Phase II Trial of Combination Gemcitabine and Carboplatin Chemotherapy in Patients With Metastatic or Recurrent Nasopharyngeal Carcinoma
The aim of the study is to assess if gemcitabine in combination with carboplatin as 1st line chemotherapy in patients with metastatic or recurrent nasopharyngeal carcinoma has reasonable efficacy and a favourable toxicity profile that warrants further comparative study. A parallel group of randomly selected patients of equal number to the carboplatin and gemcitabine combination arm will be treated with the cisplatin and 5-FU combination chemotherapy (active control arm).
The hypothesis is that this combination of chemotherapy is at least as active and less toxic than the reference regimen of cisplatin in combination with 5-fluorouracil (5-FU).
Read the detailed description
52 patients with metastatic or recurrent nasopharyngeal carcinoma who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then be randomly allocated to carboplatin and gemcitabine or cisplatin and 5-FU combinations in a ratio of 1:1. Study visits will occur depending on which arm the patient is on.
An economic evaluation of the costs and benefits of gemcitabine-carboplatin will be implemented within this protocol.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Gemcitabine, Carboplatin, Cisplatin, 5-fluorouracil (5-FU)
- Keywords
- nasopharyngeal carcinoma, Gemcitabine-Carboplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Intravenous administration on days 1, 8 of a 21-day cycle
CarboplatinDrug
Intravenous following Gemcitabine infusion on day 1
CisplatinDrug
Intravenous on day 1 prior to 5-FU infusion on days 2 to 5 of a 28-day cycle
5-fluorouracil (5-FU)Drug
Intravenous infusion on day 2 to day 5
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Gemcitabine; Drug: Carboplatin |
| B | Active comparator | Not described Receives: Drug: Cisplatin; Drug: 5-fluorouracil (5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is response to therapy. Response will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Measured: 12 months
Secondary outcomes (3)
Progression free survival defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Measured: 12 months
Duration of response defined as the interval between the first documented response (CR or PR) and the first documented sign of disease progression or death, whichever occurs first.
Measured: 12 months
Safety and tolerability assessments will consist of 1.Monitoring and recording all AE and SAE, 2.Regular monitoring of hematology, blood chemistry and urinary laboratory parameters, 3.Regular performance of physical examinations, including vital signs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Investigators
- Christina Ng, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697905
- Sponsor's protocol ID
- CT 06-01
- Status last verified
- Apr 2010
- First submitted
- 12 Jun 2008
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Labeled, Multicentre, Randomized Phase II Trial of Combination Gemcitabine and Carboplatin Chemotherapy in Patients With Metastatic or Recurrent Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00697905
- Acronym / sponsor ID
- CT 06-01
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- nasopharyngeal carcinoma, Gemcitabine-Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- Jan 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Jun 2008 (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.
The aim of the study is to assess if gemcitabine in combination with carboplatin as 1st line chemotherapy in patients with metastatic or recurrent nasopharyngeal carcinoma has reasonable efficacy and a favourable toxicity profile that warrants further comparative study. A parallel group of randomly selected patients of equal number to the carboplatin and gemcitabine combination arm will be treated with the cisplatin and 5-FU combination chemotherapy (active control arm).
The hypothesis is that this combination of chemotherapy is at least as active and less toxic than the reference regimen of cisplatin in combination with 5-fluorouracil (5-FU).
Detailed description
52 patients with metastatic or recurrent nasopharyngeal carcinoma who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then be randomly allocated to carboplatin and gemcitabine or cisplatin and 5-FU combinations in a ratio of 1:1. Study visits will occur depending on which arm the patient is on.
An economic evaluation of the costs and benefits of gemcitabine-carboplatin will be implemented within this protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Gemcitabine, Drug: Carboplatin |
| B | Active comparator | Drug: Cisplatin, Drug: 5-fluorouracil (5-FU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent obtained from patient or parents/guardian.
- Subject age greater than or equal to 18 years
- Histologically proven recurrent or metastatic undifferentiated or squamous nasopharyngeal carcinoma, not amenable to local therapy.
- Measurable disease in distant sites and/or loco-regional sites defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as >=10mm with CT scan or MRI. Tumour lesions that are situated in a previously irradiated field are measurable only if the tissue planes are preserved on CT or MRI).
- Prior concurrent chemotherapy and radiation therapy is permitted.
Key exclusion criteria (15 listed)
- Pregnant women are excluded from this study because gemcitabine has potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study.
- Women of child-bearing potential and men without an adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Prior use of gemcitabine
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or carboplatin.
- Prior lines of chemotherapy for metastatic NPC
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 |
|---|---|---|
| GemcitabineIntravenous administration on days 1, 8 of a 21-day cycle | Drug | A |
| CarboplatinIntravenous following Gemcitabine infusion on day 1 | Drug | A |
| CisplatinIntravenous on day 1 prior to 5-FU infusion on days 2 to 5 of a 28-day cycle | Drug | B |
| 5-fluorouracil (5-FU)Intravenous infusion on day 2 to day 5 | Drug | B |
Primary outcome
The primary efficacy variable is response to therapy. Response will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Time frame: 12 months
3 secondary outcomes
Progression free survival defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Time frame: 12 months
Duration of response defined as the interval between the first documented response (CR or PR) and the first documented sign of disease progression or death, whichever occurs first.
Time frame: 12 months
Safety and tolerability assessments will consist of 1.Monitoring and recording all AE and SAE, 2.Regular monitoring of hematology, blood chemistry and urinary laboratory parameters, 3.Regular performance of physical examinations, including vital signs
Time frame: 12 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 21 Nov 2014.
- Related InfoLink provided by the sponsor.
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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.
Christina Ng principal investigator
University of Malaya
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Carboplatin and Cisplatin in people with Nasopharyngeal Carcinoma, run by Ministry of Health, Malaysia at 11 sites in Malaysia.
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 15 inclusion and 15 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 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in 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?
The primary efficacy variable is response to therapy. Response will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. (time frame: 12 months). 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 21 Nov 2014.