Cancer of the Head and NeckPhase 2NCT01370876
Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase 2 study testing Oxaliplatin in people with Cancer of the Head and Neck and Neoplasms, Head and Neck, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
Trial summary
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen. Read more about this study
- Who is it for?
- Ages 20 to 75 years, men only
- Conditions the study is for
- Cancer of the Head and Neck, Neoplasms, Head and Neck
- What is being tested?
- Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to May 2012
- 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 20 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have been histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) except nasopharyngeal cancer.
- Patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective.
- Prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment.
- The disease must have been measurable by computed tomographic (CT) scan or MRI (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm.
- Patients must be 20 years of age and 75 years of age.
- Patients must have an ECOG performance status score 2.
- Patient's hematologic function, liver function and renal function must meet the eligibility requirements.
- Patients must sign the informed consent.
Who cannot join
- Patients with known hypersensitivity history to Platinum compounds or to 5-Fluorouracil.
- Patients with brain metastases.
- Patients with bone metastases only.
- Patients with pregnancy or breast-feeding.
- Patient with CTC (NCI Common Toxicity Criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable.
- Patients who have serious concomitant illness that might be aggravated by chemotherapy and other conditions which will be judged by physician's discretion.
- Patients who are receiving other anticancer cancer drug(s) for SCCHN.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial Evaluating Efficacy and Safety of Opatin® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.
Read the detailed description
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer.
To assess the safety profile of these treatment regimen. To evaluate the duration of response of oxaliplatin/5-FU.
- Being tested
- Oxaliplatin
- Keywords
- Oxaliplatin, Head and Neck cancer
- 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.
OxaliplatinDrug
Also called Opatin
Oxaliplatin will be administered as a 2-hour infusion first on Day 1, followed by 5-FU i.v. infusion for 48 hours (Day 1 and Day 2), repeated every 2 weeks, 4 weeks as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin/5-FU | Experimental | Not described Receives: Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer
Measured: every 12 weeks
Secondary outcomes (1)
Safety
To assess number of participants with adverse events of these treatment regimen
Measured: Each patient will be followed for 30 days after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionMay 2012
Why it stopped: company policy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Chang Yi Fan, M.D., Principal investigator, Taipei Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370876
- Sponsor's protocol ID
- 10CT006A
- Status last verified
- Dec 2013
- First submitted
- 28 Mar 2011
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating Efficacy and Safety of Opatin® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01370876
- Acronym / sponsor ID
- 10CT006A
- Keywords
- Oxaliplatin, Head and Neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company policy
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Jun 2011 (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.
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.
Detailed description
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer.
To assess the safety profile of these treatment regimen. To evaluate the duration of response of oxaliplatin/5-FU.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin/5-FU | Experimental | Drug: Oxaliplatin |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have been histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) except nasopharyngeal cancer.
- Patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective.
- Prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment.
- The disease must have been measurable by computed tomographic (CT) scan or MRI (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm.
- Patients must be 20 years of age and 75 years of age.
Key exclusion criteria (7 listed)
- Patients with known hypersensitivity history to Platinum compounds or to 5-Fluorouracil.
- Patients with brain metastases.
- Patients with bone metastases only.
- Patients with pregnancy or breast-feeding.
- Patient with CTC (NCI Common Toxicity Criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable.
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 |
|---|---|---|
| OxaliplatinAlso: OpatinOxaliplatin will be administered as a 2-hour infusion first on Day 1, followed by 5-FU i.v. infusion for 48 hours (Day 1 and Day 2), repeated every 2 weeks, 4 weeks as a cycle. | Drug | Oxaliplatin/5-FU |
Primary outcome
Objective response rate
Time frame: every 12 weeks
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer
1 secondary outcome
Safety
Time frame: Each patient will be followed for 30 days after the last dose of study medication
Results and safety
The study was stopped early (reason given: company policy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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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.
Chang Yi Fan, M.D. principal investigator
Taipei Mackay Memorial Hospital
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 Oxaliplatin in people with Cancer of the Head and Neck and Neoplasms, Head and Neck, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
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 8 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: stopped early, as of the sponsor's last update on 10 Dec 2013. 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 Taiwan. 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: company policy). 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?
Objective response rate (time frame: every 12 weeks). 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 10 Dec 2013.