Nasopharyngeal NeoplasmsPhase 2NCT00436800
Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Gemcitabine and Oxaliplatin in people with Nasopharyngeal Neoplasms, run by Sanofi at 1 site in Hong Kong.
Trial summary
Primary objective: To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Neoplasms
- What is being tested?
- Gemcitabine and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2005to Oct 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
- Patients with histologically or cytologically proven nasopharyngeal carcinoma (NPC) with metastatic or recurrent disease that is not amenable to potentially curative surgery or radiotherapy. They must not have prior chemotherapy for the treatment of metastatic or recurrent disease.
- Prior neoadjuvant, adjuvant or concurrent chemotherapy is allowed as long as a minimum period of 6 weeks has elapsed since the last day of treatment. This includes the use of carboplatin or cisplatin.
- Patients must have at least one uni-dimensional measurable lesion (according to RECIST criteria)
- Prior RT or surgery to the target lesion(s) is allowed as long as there is documented disease progression within the RT/ surgical field, and a minimum period of 6 weeks has elapsed since the last day of treatment.
- Eastern Cooperative Oncology Group performance status of 0-2
- No serious, uncontrolled medical conditions that may be aggravated by treatment.
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- No other malignancy(s), except completely excised basal or squamous cell carcinoma of the skin, or completely treated carcinoma-in-situ of the cervix.
- Adequate hematological function:absolute granulocyte count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L
- Adequate renal and hepatic functions:·serum creatinine < 1.25 x upper normal limit (UNL) or a calculated creatinine clearance > 50 mL/min·serum bilirubin < 2 x UNL and Aspartate aminotransferase/Alanine aminotransferase < 3 x UNL
Who cannot join
- Prior treatment with Oxaliplatin or Gemcitabine.
- Patients who have persistent grade 2 or more sensory and/or motor neuropathy, or ototoxicity resulting from prior cisplatin/ carboplatin.
- Active or past history of central nervous system metastasis from the primary tumor
- Potentially life-threatening infections
- Patients have used any investigational drug treatment in the month prior to inclusion.
- Pregnancy or not exercising appropriate birth control during the course of the study. Breast-feeding women
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)
Primary objective:
To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma.
Secondary objectives:
To assess the toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms in the first line treatment of patients with metastatic or recurrent NPC.
- Conditions
- Nasopharyngeal Neoplasms
- Being tested
- Gemcitabine, Oxaliplatin
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
1000mg/m² over 10mg/m²/min
OxaliplatinDrug
100 mg/m² over 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gemcitabine on Day 1 followed by Oxaliplatin on Day 2. The regimen is given every 2 weeks to a maximum of 12 cycles. Receives: Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria
Measured: Baseline to end of study
Safety: Clinical and laboratory criteria
Measured: Baseline to end of study
The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
Measured: Baseline to 30 days post treatment
Occurrence of serious adverse events (SAE)
Measured: Baseline to 30 days post treatment
Drop-out rate
Measured: End of study
Secondary outcomes (1)
Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms.
Measured: Baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startMar 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iris Chan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436800
- Sponsor's protocol ID
- L_9281
- Status last verified
- Aug 2009
- First submitted
- 16 Feb 2007
- Last updated
- 18 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT00436800
- Acronym / sponsor ID
- L_9281
- Conditions
- Nasopharyngeal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Feb 2007 (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.
Primary objective:
To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma.
Secondary objectives:
To assess the toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms in the first line treatment of patients with metastatic or recurrent NPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Gemcitabine, Drug: OxaliplatinGemcitabine on Day 1 followed by Oxaliplatin on Day 2. The regimen is given every 2 weeks to a maximum of 12 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically or cytologically proven nasopharyngeal carcinoma (NPC) with metastatic or recurrent disease that is not amenable to potentially curative surgery or radiotherapy. They must not have prior chemotherapy for the treatment of metastatic or recurrent disease.
- Prior neoadjuvant, adjuvant or concurrent chemotherapy is allowed as long as a minimum period of 6 weeks has elapsed since the last day of treatment. This includes the use of carboplatin or cisplatin.
- Patients must have at least one uni-dimensional measurable lesion (according to RECIST criteria)
- Prior RT or surgery to the target lesion(s) is allowed as long as there is documented disease progression within the RT/ surgical field, and a minimum period of 6 weeks has elapsed since the last day of treatment.
- Eastern Cooperative Oncology Group performance status of 0-2
Key exclusion criteria (7 listed)
- Prior treatment with Oxaliplatin or Gemcitabine.
- Patients who have persistent grade 2 or more sensory and/or motor neuropathy, or ototoxicity resulting from prior cisplatin/ carboplatin.
- Active or past history of central nervous system metastasis from the primary tumor
- Potentially life-threatening infections
- Patients have used any investigational drug treatment in the month prior to inclusion.
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 |
|---|---|---|
| Gemcitabine1000mg/m² over 10mg/m²/min | Drug | 1 |
| Oxaliplatin100 mg/m² over 2 hours. | Drug | 1 |
Primary outcome
Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria
Time frame: Baseline to end of study
Safety: Clinical and laboratory criteria
Time frame: Baseline to end of study
The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
Time frame: Baseline to 30 days post treatment
Occurrence of serious adverse events (SAE)
Time frame: Baseline to 30 days post treatment
Drop-out rate
Time frame: End of study
1 secondary outcome
Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms.
Time frame: Baseline to end of study
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 18 Sep 2009.
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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.
Iris Chan study director
Sanofi
1 site 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 and Oxaliplatin in people with Nasopharyngeal Neoplasms, run by Sanofi at 1 site in Hong Kong.
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 7 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 18 Sep 2009. 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 Hong Kong. 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?
Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria (time frame: Baseline to end of study). The study lists 5 primary outcomes in all. 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 18 Sep 2009.