Cancer of the Head and NeckPhase 2NCT00256295
Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic Head and Neck Cancer
A Phase 2 study testing Gemcitabine and Oxaliplatin in people with Cancer of the Head and Neck, run by Sai-Hong Ignatius Ou at 1 site in United States.
Trial summary
The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck
- What is being tested?
- Gemcitabine and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All patients must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. Primary tumor sites include: lip, oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis, glottis, subglottis). For nasopharynx primary, all squamous histologic subtypes are allowed (WHO type-I keratinizing, WHO type-II non-keratinizing, WHO type-III undifferentiated).
- Patients must have metastatic or locally recurrent carcinoma of the head and neck. Patients with locoregional disease must be considered incurable by means of locoregional therapy.
- All sites of disease must be assessed and designated as measurable or non-measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable disease must be assessed within 28 days prior to registration. All non-measurable disease must be assessed within 42 days prior to registration.
- Patients may have received prior radiotherapy if there has been complete recovery from all radiation-induced toxicities. At least 4 weeks must have been elapsed from the completion of radiation therapy to the time of registration. If lesions within the radiation port are to be used to assess response to therapy, those lesions must have demonstrated clear progression following completion of radiation therapy.
- Patients must have adequate bone marrow reserve as documented by absolute neutrophil count (ANC) > 1,500 microliters and platelets > 100,000/microliter obtained within 14 days prior to registration.
- Patients must have adequate hepatic as documented by serum bilirubin < 1.5 x the institutional upper limit of normal. Serum transaminase (SGOT or SGPT) must be < 1.5 x the institutional upper limit of normal serum unless the liver is involved with tumor, in which case serum transaminase (SGOT or SGPT) must be < 5 x the institutional limit of normal. These tests must be obtained within 14 days prior to registration.
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- Patients must have a creatinine < 1.5 x the institutional upper limit of normal or a creatinine clearance of > 30 cc/min calculated using the following formula obtained within 28 days prior to registration.
- Calculated Creatinine Clearance = (140-age) X wt (kg) X (0.85 if female) 72 X creatinine (mg/dl)
- These tests must have been performed within 28 days prior to registration.
- All patients must be 18 years of age or older
- Patients must have a Zubrod performance of 0-2
Who cannot join
- Patients must not have more than one prior chemotherapy regimen for recurrent/metastatic disease. Patients with initial locally advanced but non-metastatic disease are allowed to have one prior chemotherapy regimen as part of the primary curative therapy. All chemotherapy must be completed 4 weeks prior to registration. Any number of prior biologic therapies (e.g. chimeric antibodies or kinase inhibitors) is permitted as part of the chemotherapy regimen.
- Patients must not have a surgical treatment procedure for head and neck cancer within 4 weeks prior to registration. Surgical procedure for biopsy purpose alone is allowed within 28 days prior to registration. Patients must have completely recovered from all surgery prior to registration.
- Patients must not have prior therapy with oxaliplatin or gemcitabine
- Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life threatening arrhythmia are not eligible.
- Patients with severe psychiatric disorder are not eligible.
- Patients with known brain metastasis are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain-imaging studies are performed, they must be negative for disease.
- No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: A Phase II Study of Weekly Oxaliplatin and Gemcitabine Combination Chemotherapy for Recurrent or Metastatic Head and Neck Cancer
The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8 oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was 16% with no incidence of febrile neutropenia.
Toxicity is a crucial consideration when designing regimens intended for palliation. Toxicities associated with cisplatin can make it difficult to use in patients with Head and Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant therapy, or as part of their primary chemoradiation treatment. When these patients recur, it is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely to be better tolerated than cisplatin containing regimens, especially with regards to neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen.
- Conditions
- Cancer of the Head and Neck
- Being tested
- Gemcitabine, Oxaliplatin
- Keywords
- Cancer of the Head and Neck
- 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.
GemcitabineDrug
Also called Gemzar, NSC-613327
1000 mg/m2 IV over 100 minutes Every 21 days
OxaliplatinDrug
Also called NSC-266046
65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine plus Oxaliplatin | Experimental | Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days. Receives: Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (Complete and Partial Response)
Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same techniques as baseline.
Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.
Measured: 5 years
Secondary outcomes (2)
Frequency and Severity of Toxicities
Measured: 5 years
Overall Survival and Time to Treatment Failure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startApr 2005
- Primary completionFeb 2008
- Study completionOct 2011
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sai-Hong Ignatius Ou
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Sai-Hong Ignatius Ou, University of California, Irvine
- Investigators
- Ignatius Ou, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256295
- Sponsor's protocol ID
- UCI 04-08
- Other IDs
- 2004-3776
- Status last verified
- Dec 2016
- First submitted
- 17 Nov 2005
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Weekly Oxaliplatin and Gemcitabine Combination Chemotherapy for Recurrent or Metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00256295
- Acronym / sponsor ID
- UCI 04-08
- Conditions
- Cancer of the Head and Neck
- Keywords
- Cancer of the Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sai-Hong Ignatius OuUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Apr 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Posted 25 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic, germ cell, breast, biliary, mesothelioma (Mitchell et al, 2002), and lung. In the last study which utilized days 1 and 8 gemcitabine 1000 mg/m2 and days 1 and 8 oxaliplatin 65 mg/m2 in poor prognosis lung cancer patients (PS 1-3) the response rate was 16% with no incidence of febrile neutropenia.
Toxicity is a crucial consideration when designing regimens intended for palliation. Toxicities associated with cisplatin can make it difficult to use in patients with Head and Neck Cancer (HNC), many of whom are elderly and have comorbidities. In addition, many patients with metastatic HNC have previously received cisplatin during neoadjuvant/adjuvant therapy, or as part of their primary chemoradiation treatment. When these patients recur, it is possible their tumors have innate or acquired cisplatin resistance. Oxaliplatin is likely to be better tolerated than cisplatin containing regimens, especially with regards to neurotoxicity. Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC. A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine plus Oxaliplatin | Experimental | Drug: Gemcitabine, Drug: OxaliplatinGemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All patients must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. Primary tumor sites include: lip, oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis, glottis, subglottis). For nasopharynx primary, all squamous histologic subtypes are allowed (WHO type-I keratinizing, WHO type-II non-keratinizing, WHO type-III undifferentiated).
- Patients must have metastatic or locally recurrent carcinoma of the head and neck. Patients with locoregional disease must be considered incurable by means of locoregional therapy.
- All sites of disease must be assessed and designated as measurable or non-measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable disease must be assessed within 28 days prior to registration. All non-measurable disease must be assessed within 42 days prior to registration.
- Patients may have received prior radiotherapy if there has been complete recovery from all radiation-induced toxicities. At least 4 weeks must have been elapsed from the completion of radiation therapy to the time of registration. If lesions within the radiation port are to be used to assess response to therapy, those lesions must have demonstrated clear progression following completion of radiation therapy.
- Patients must have adequate bone marrow reserve as documented by absolute neutrophil count (ANC) > 1,500 microliters and platelets > 100,000/microliter obtained within 14 days prior to registration.
Key exclusion criteria (7 listed)
- Patients must not have more than one prior chemotherapy regimen for recurrent/metastatic disease. Patients with initial locally advanced but non-metastatic disease are allowed to have one prior chemotherapy regimen as part of the primary curative therapy. All chemotherapy must be completed 4 weeks prior to registration. Any number of prior biologic therapies (e.g. chimeric antibodies or kinase inhibitors) is permitted as part of the chemotherapy regimen.
- Patients must not have a surgical treatment procedure for head and neck cancer within 4 weeks prior to registration. Surgical procedure for biopsy purpose alone is allowed within 28 days prior to registration. Patients must have completely recovered from all surgery prior to registration.
- Patients must not have prior therapy with oxaliplatin or gemcitabine
- Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life threatening arrhythmia are not eligible.
- Patients with severe psychiatric disorder are not eligible.
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 |
|---|---|---|
| GemcitabineAlso: Gemzar, NSC-6133271000 mg/m2 IV over 100 minutes Every 21 days | Drug | Gemcitabine plus Oxaliplatin |
| OxaliplatinAlso: NSC-26604665 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days | Drug | Gemcitabine plus Oxaliplatin |
Primary outcome
Overall Response Rate (Complete and Partial Response)
Time frame: 5 years
Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same techniques as baseline. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.
2 secondary outcomes
Frequency and Severity of Toxicities
Time frame: 5 years
Overall Survival and Time to Treatment Failure
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ignatius Ou, MD principal investigator
Chao Family Comprehensive Cancer Center
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 Cancer of the Head and Neck, run by Sai-Hong Ignatius Ou at 1 site 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 11 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 1 Feb 2017. 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 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?
Yes. Results are posted in the registry (first posted 25 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (Complete and Partial Response) (time frame: 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 1 Feb 2017.