Non-small Cell Lung CancerPhase 1NCT00901537
Azacitidine and Cisplatin in Patients With Advanced Lung or Head and Neck Cancer
A Phase 1 study testing Azacitidine and Cisplatin in people with Non-small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck, run by Loma Linda University at 1 site in United States.
Trial summary
The standard of care for head and neck and lung cancer includes chemotherapy, radiation and surgery. For patients with cancer of head and neck or lung that recurs after surgery and/or radiation, or has spread to other parts of body, chemotherapy using cisplatin can slow down tumor growth and extend lifespan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Azacitidine and Cisplatin
- 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
- Feb 2009to Oct 2011
- Phase
- Phase 1
- 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 must have histologically proven squamous cell carcinoma of head and neck or non-small cell lung cancer that is either metastatic or has persisted or recurred following definitive surgery and/or radiation therapy, and is not amenable to salvage surgical resection.
- Patients may have received previous chemotherapy and/or biological treatment such as cetuximab, bevacizumab or erlotinib) for the recurrent or metastatic disease. Prior treatment must have been completed at least 28 days (42 days for nitrosoureas or mitomycin C) prior to entering the study and all toxicities must have been resolved. Patients who have received prior treatment with EGFR inhibitor alone such as cetuximab or erlotinib are allowed to enter the study at least 14 days after receiving the last dose of the prior treatment.
- Prior radiation must have been completed at least 28 days before entry into the study and all toxicities must have been resolved (no more than 3000 cGy to fields including substantial marrow).
- Surgery must have been completed at least 28 days 28 days before entry into the study and all complications/adverse events must have been resolved.
- Age >18 years.
- ECOG performance status <2 (Karnofsky >60%).
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- Life expectancy of greater than 3 months.
- Patients must have normal organ and marrow function
- Patients must not be planning to receive any other concurrent therapy (i.e. radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) while they are on this study.
- Patients must be able to understand and sign a written informed consent document approved for this trial.
- Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
Who cannot join
- Patients with symptomatic brain metastases are excluded from this clinical trial. Patients with asymptomatic brain metastases are allowed. The patient must be stable for 2 weeks after radiotherapy; if the patient is on corticosteroids, the dose of cortico steroids must have been stable for 2 weeks prior to first dose of study treatment, or be in the process of being tapered.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, cisplatin and mannitol or other agents used in study.
- Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients known to be HIV-positive are not eligible because of the potential to confound this study's endpoints.
- No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Cancer Center
Loma Linda, California, 92354
About this study
Official title: Phase I Study of Azacitidine in Combination With Cisplatin in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer or Squamous Cell Carcinoma of the Head and Neck
The standard of care for head and neck and lung cancer includes chemotherapy, radiation and surgery. For patients with cancer of head and neck or lung that recurs after surgery and/or radiation, or has spread to other parts of body, chemotherapy using cisplatin can slow down tumor growth and extend lifespan.
The study drug, azacitidine, can block the ability of some cancer cells to replicate, and has been approved by the Food and Drug Administration for use in myelodysplastic syndrome, which is a slowly developing blood cell-related cancer. In laboratory and animal experiments using head and neck and lung cancer cells, azacitidine has been shown to be a cisplatin "helper", (that is, it makes cisplatin more effective in stopping the growth of head and neck and lung cancer. )
Since the combination of azacitidine and cisplatin has not been used in patients with head and neck or lung cancer, the investigators are performing this study combining azacitidine and cisplatin to find out what effects, good and/or bad, the study drug may have on patients with advanced head and neck or lung cancer. The investigators are doing this study because they would like to find a better treatment for these types of cancer.
Read the detailed description
Azacitidine will be given with standard dose of cisplatin. At the beginning of the study, three patients will be treated with low dose of azacitidine. If that dose does not cause bad side effects, then the dose will slowly be made higher for new patients who take part in the study.
Patients will receive azacitidine as a once-a-day subcutaneous (under the skin) injection every day from day 1 to day 5 of 28 days in this study. Cisplatin is given intravenously on day 8. This 28-day or 4-week period of time is called a cycle. Cycles are repeated every four weeks for as long as the physician recommends.
During this study, patients will need the following tests and procedures.
- Physical exam - This will be done weekly during first 2 weeks of every 4-week treatment cycle.
- Blood tests for blood counts - These will be done every week.
- Blood tests for kidney function, liver function, and to measure electrolytes - These will be done every week
- Blood samples for research study - This will be done weekly during first cycle, then weekly during the first 2 weeks on the subsequent treatment cycles
- X-rays or scans - These will be done once every 8 weeks.
- Being tested
- Azacitidine and Cisplatin
- Keywords
- Non-small Cell Lung Cancer, Head and Neck Cancer, Azacitidine, Vidaza, Cisplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine and CisplatinDrug
Also called Vidaza, 5-Azacytidine
We plan to give azacitidine daily as subcutaneous injection at escalated doses (37, 60, 75, 85, 100 and 110 mg/m2) for 5 days from day 1 to day 5, and give cisplatin 75 mg/m2 as intravenous injection on day 8, every 4 weeks as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine and Cisplatin | Experimental | Every 4 weeks, azacitidine is given daily as subcutaneous injection for 5 days from day 1 to day 5, and cisplatin is given as intravenous injection on day 8. The dose of azacitidine will be dose escalated among each group of 3-6 patients, and the dose of cisplatin is fixed. Receives: Drug: Azacitidine and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and toxicity of azacitidine and cisplatin combination.
Measured: weekly for first 4 weeks, then weekly times 2 for every 4 weeks
Secondary outcomes (1)
Determine the biologically effective dose of azacitidine, maximum tolerated dose of azacitidine and cisplatin combination, and tumor response
Measured: every 8 weeks for response evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2011
- Study completionOct 2011
Why it stopped: Sponsor terminated due to no enrollments within last 4 months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung-Tsen Hsueh, Loma Linda University
- Investigators
- Chung-Tsen Hsueh, MD, PhD, Principal investigator, Loma Linda University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901537
- Sponsor's protocol ID
- 58358
- Other IDs
- IND 105076 (IND Exempt)
- Status last verified
- Apr 2018
- First submitted
- 12 May 2009
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Azacitidine in Combination With Cisplatin in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer or Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00901537
- Acronym / sponsor ID
- 58358
- Keywords
- Non-small Cell Lung Cancer, Head and Neck Cancer, Azacitidine, Vidaza, Cisplatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated due to no enrollments within last 4 months.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 May 2009 (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 standard of care for head and neck and lung cancer includes chemotherapy, radiation and surgery. For patients with cancer of head and neck or lung that recurs after surgery and/or radiation, or has spread to other parts of body, chemotherapy using cisplatin can slow down tumor growth and extend lifespan.
The study drug, azacitidine, can block the ability of some cancer cells to replicate, and has been approved by the Food and Drug Administration for use in myelodysplastic syndrome, which is a slowly developing blood cell-related cancer. In laboratory and animal experiments using head and neck and lung cancer cells, azacitidine has been shown to be a cisplatin "helper", (that is, it makes cisplatin more effective in stopping the growth of head and neck and lung cancer. )
Since the combination of azacitidine and cisplatin has not been used in patients with head and neck or lung cancer, the investigators are performing this study combining azacitidine and cisplatin to find out what effects, good and/or bad, the study drug may have on patients with advanced head and neck or lung cancer. The investigators are doing this study because they would like to find a better treatment for these types of cancer.
Detailed description
Azacitidine will be given with standard dose of cisplatin. At the beginning of the study, three patients will be treated with low dose of azacitidine. If that dose does not cause bad side effects, then the dose will slowly be made higher for new patients who take part in the study.
Patients will receive azacitidine as a once-a-day subcutaneous (under the skin) injection every day from day 1 to day 5 of 28 days in this study. Cisplatin is given intravenously on day 8. This 28-day or 4-week period of time is called a cycle. Cycles are repeated every four weeks for as long as the physician recommends.
During this study, patients will need the following tests and procedures.
- Physical exam - This will be done weekly during first 2 weeks of every 4-week treatment cycle.
- Blood tests for blood counts - These will be done every week.
- Blood tests for kidney function, liver function, and to measure electrolytes - These will be done every week
- Blood samples for research study - This will be done weekly during first cycle, then weekly during the first 2 weeks on the subsequent treatment cycles
- X-rays or scans - These will be done once every 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacitidine and Cisplatin | Experimental | Drug: Azacitidine and CisplatinEvery 4 weeks, azacitidine is given daily as subcutaneous injection for 5 days from day 1 to day 5, and cisplatin is given as intravenous injection on day 8. The dose of azacitidine will be dose escalated among each group of 3-6 patients, and the dose of cisplatin is fixed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically proven squamous cell carcinoma of head and neck or non-small cell lung cancer that is either metastatic or has persisted or recurred following definitive surgery and/or radiation therapy, and is not amenable to salvage surgical resection.
- Patients may have received previous chemotherapy and/or biological treatment such as cetuximab, bevacizumab or erlotinib) for the recurrent or metastatic disease. Prior treatment must have been completed at least 28 days (42 days for nitrosoureas or mitomycin C) prior to entering the study and all toxicities must have been resolved. Patients who have received prior treatment with EGFR inhibitor alone such as cetuximab or erlotinib are allowed to enter the study at least 14 days after receiving the last dose of the prior treatment.
- Prior radiation must have been completed at least 28 days before entry into the study and all toxicities must have been resolved (no more than 3000 cGy to fields including substantial marrow).
- Surgery must have been completed at least 28 days 28 days before entry into the study and all complications/adverse events must have been resolved.
- Age >18 years.
Key exclusion criteria (6 listed)
- Patients with symptomatic brain metastases are excluded from this clinical trial. Patients with asymptomatic brain metastases are allowed. The patient must be stable for 2 weeks after radiotherapy; if the patient is on corticosteroids, the dose of cortico steroids must have been stable for 2 weeks prior to first dose of study treatment, or be in the process of being tapered.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, cisplatin and mannitol or other agents used in study.
- Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients known to be HIV-positive are not eligible because of the potential to confound this study's endpoints.
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 |
|---|---|---|
| Azacitidine and CisplatinAlso: Vidaza, 5-AzacytidineWe plan to give azacitidine daily as subcutaneous injection at escalated doses (37, 60, 75, 85, 100 and 110 mg/m2) for 5 days from day 1 to day 5, and give cisplatin 75 mg/m2 as intravenous injection on day 8, every 4 weeks as a cycle. | Drug | Azacitidine and Cisplatin |
Primary outcome
Evaluate the safety and toxicity of azacitidine and cisplatin combination.
Time frame: weekly for first 4 weeks, then weekly times 2 for every 4 weeks
1 secondary outcome
Determine the biologically effective dose of azacitidine, maximum tolerated dose of azacitidine and cisplatin combination, and tumor response
Time frame: every 8 weeks for response evaluation
Results and safety
The study was stopped early (reason given: Sponsor terminated due to no enrollments within last 4 months.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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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.
Chung-Tsen Hsueh, MD, PhD principal investigator
Loma Linda University 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 1 study testing Azacitidine and Cisplatin in people with Non-small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck, run by Loma Linda University 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 6 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 17 Apr 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Sponsor terminated due to no enrollments within last 4 months.). 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?
Evaluate the safety and toxicity of azacitidine and cisplatin combination. (time frame: weekly for first 4 weeks, then weekly times 2 for every 4 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 17 Apr 2018.