Cancer of Head and NeckPhase 2NCT02013453
A Phase II Trial of Proton Pump Inhibitors With Chemotherapy in Patients With Metastatic Head and Neck Cancer
A Phase 2 study testing Omeprazole, Carboplatin and 5FU in people with Cancer of Head and Neck, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if the addition of proton pump inhibitors (PPIs) to standard chemotherapy can improve progression free survival in patients with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Omeprazole, Carboplatin and 5FU
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2016
- 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
- Males and non-pregnant, non-lactating females at least 18 years old.
- Histologically or cytologically confirmed diagnosis of SCCHN (Squamous Cell Carcinoma of the Head and Neck).
- Stage IVC (metastatic) or advanced, locally recurrent SCCHN not amenable to curative surgery or radiotherapy.
- Measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors) vs 1.1 (Appendix 1).
- If the only site of measurable disease for this study is within a prior field of irradiation, then the sum of the longest diameters (SLD) of that lesion must have increased by at least 20% from the prior treatment nadir.
- ECOG Performance status (measure of health and general well being on a scale of 0 to 5 where 0 represents perfect health) < 1 (Appendix 2).
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- Expected survival of at least 3 months.
- Adequate liver and renal function that is defined as Calculated creatinine clearance of <30ml/min (by Jelliffe calculator) AST (aspartate aminotransferase)/ALT (alanine aminotransferase) < 2.5 X ULN (unless there are hepatic metastasis, in which case AST/ALT within 5 X ULN) Total Bilirubin < 1.5 X ULN (Appendix 5).
- Ability to understand and willingness to sign an informed consent form.
- Willingness and ability to comply with study procedures and follow up.
- There is no restriction on number of prior therapies as long as the patient is deemed a candidate for palliative chemotherapy with one of the standard chemotherapy regimens.
- Willingness to use contraception by a method that is deemed effective by the Investigator by both male and female patients of childbearing potential and their partners throughout the treatment period and for at least 30 days following the last cycle of chemotherapy (post menopausal women must have been amenorrheal for at-least 12 months to be considered of non-childbearing potential).
Who cannot join
- Comorbidities precluding treatment with combination chemotherapy or per investigator discretion.
- Pregnancy or lactation.
- Medical or psychiatric illness that may compromise the patient's ability to tolerate the treatment or comply with the study requirements.
- Patients with another active cancer or history of another cancer in the last 3 years except those treated with curative intent such as skin cancer (other than melanoma), in situ breast or in situ cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 2 years.
- Allergy to PPI or inability to tolerate PPI.
- Patients residing in prison.
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- Any investigational drug dose within 28 days of planned start of trial.
- Any concurrent standard therapy intended to treat SCCHN.
- Any symptomatic infection (bacterial, fungal or viral) as per the investigator discretion.
- Patients with uncontrolled CNS (Central Nervous System) metastases are excluded. Patients with known, previously treated CNS metastases are eligible if they are neurologically stable as per the investigating physician's clinical assessment.
- Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
- Patients on Rilpivirine, Atazanavir, Indinavir and Nelfinavir will not be eligible for participation in study because of the significant drug interaction unless the patient can be switched to a different antiviral medication prior to study enrollment.
- Omeprazole can increase the serum concentration of methotrexate, clorazepate and citalopram increasing the risk of adverse effects.
- Omeprazole may result in reduction in clinical efficacy of clopidogrel and increased risk for thrombosis.
- Omeprazole when co-administered with dasatinib, bosutinib, ponatinib, erlotinib, dabrafenib and vismodegib reduces the systemic exposure to these drugs, therefore patients on these drugs should not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: A Phase II Randomized Trial Evaluating the Use of Proton Pump Inhibitors (PPIs) in Conjunction With Chemotherapy, in Patients With Recurrent Unresectable or Metastatic Cancers of the Head and Neck
The purpose of this study is to determine if the addition of proton pump inhibitors (PPIs) to standard chemotherapy can improve progression free survival in patients with head and neck cancer.
- Conditions
- Cancer of Head and Neck
- Being tested
- Omeprazole, Carboplatin, 5FU, Paclitaxel, Pemetrexed
- 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.
OmeprazoleDrug
40mg of Omeprazole will be administered daily by mouth.
CarboplatinDrug
Carboplatin will be administered over 30 minutes by continuous infusion.
5FUDrug
Also called 5-Fluorouracil, Efudex
Administered by infusion.
PaclitaxelDrug
Administered by infusion.
PemetrexedDrug
Administered by infusion.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Active comparator | Patients on the Observational arm are currently being treated with a proton pump inhibitor (PPIs) such as Omeprazole. They will receive standard of care chemotherapy. Standard treatment is the choice of the treating physician and may include Carboplatin in combination with either 5FU, Paclitaxel, or Pemetrexed. Receives: Drug: Omeprazole; Drug: Carboplatin; Drug: 5FU; Drug: Paclitaxel; Drug: Pemetrexed |
| Standard Chemo + Placebo | Active comparator | Patients on the Standard Chemo and Placebo arm are not currently being treated with a proton pump inhibitor (PPI). They will be randomized to receive placebo along with standard of care chemotherapy. Standard treatment is the choice of the treating physician and may include Carboplatin in combination with either 5FU, Paclitaxel, or Pemetrexed. Receives: Drug: Carboplatin; Drug: 5FU; Drug: Paclitaxel; Drug: Pemetrexed |
| Standard Chemo + Omeprazole | Experimental | Patients on the Standard Chemo and Placebo arm are not currently being treated with a proton pump inhibitor (PPI). They will be randomized to receive Omeprazole along with standard of care chemotherapy. Standard treatment is the choice of the treating physician and may include Carboplatin in combination with either 5FU, Paclitaxel, or Pemetrexed. Receives: Drug: Omeprazole; Drug: Carboplatin; Drug: 5FU; Drug: Paclitaxel; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
The primary aim, progression-free survival, will be defined from start of treatment to date of first progression and will be tested using a Cox proportional hazard regression model with treatment arm as the only predictor.
Measured: 6 months post treatment
Secondary outcomes (2)
Median overall survival
Overall survival be evaluated with Cox models and will be defined from the first date of treatment to date of death.
Measured: 6 months post treatment
Proportion of patients that experience a response to treatment
Estimate the proportion of patients with a complete response (CR), partial response (PR), objective response (CR+PR) and clinical benefit (CR+PR+Stable disease) and compare responses between the group receiving proton pump inhibitors (PPI) and the group not receiving PPIs.
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Worden, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013453
- Sponsor's protocol ID
- UMCC 2013.046
- Other IDs
- HUM00074951
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial Evaluating the Use of Proton Pump Inhibitors (PPIs) in Conjunction With Chemotherapy, in Patients With Recurrent Unresectable or Metastatic Cancers of the Head and Neck
- ClinicalTrials.gov ID
- NCT02013453
- Acronym / sponsor ID
- UMCC 2013.046
- Conditions
- Cancer of Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 17 Dec 2013 (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 purpose of this study is to determine if the addition of proton pump inhibitors (PPIs) to standard chemotherapy can improve progression free survival in patients with head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational | Active comparator | Drug: Omeprazole, Drug: Carboplatin, Drug: 5FU, Drug: Paclitaxel, Drug: PemetrexedPatients on the Observational arm are currently being treated with a proton pump inhibitor (PPIs) such as Omeprazole. They will receive standard of care chemotherapy. Standard treatment is the choice of the treating physician and may include Carboplatin in combination with either 5FU, Paclitaxel, or Pemetrexed. |
| Standard Chemo + Placebo | Active comparator | Drug: Carboplatin, Drug: 5FU, Drug: Paclitaxel, Drug: PemetrexedPatients on the Standard Chemo and Placebo arm are not currently being treated with a proton pump inhibitor (PPI). They will be randomized to receive placebo along with standard of care chemotherapy. Standard treatment is the choice of the treating physician and may include Carboplatin in combination with either 5FU, Paclitaxel, or Pemetrexed. |
| Standard Chemo + Omeprazole | Experimental | Drug: Omeprazole, Drug: Carboplatin, Drug: 5FU, Drug: Paclitaxel, Drug: PemetrexedPatients on the Standard Chemo and Placebo arm are not currently being treated with a proton pump inhibitor (PPI). They will be randomized to receive Omeprazole along with standard of care chemotherapy. Standard treatment is the choice of the treating physician and may include Carboplatin in combination with either 5FU, Paclitaxel, or Pemetrexed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and non-pregnant, non-lactating females at least 18 years old.
- Histologically or cytologically confirmed diagnosis of SCCHN (Squamous Cell Carcinoma of the Head and Neck).
- Stage IVC (metastatic) or advanced, locally recurrent SCCHN not amenable to curative surgery or radiotherapy.
- Measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors) vs 1.1 (Appendix 1).
- ECOG Performance status (measure of health and general well being on a scale of 0 to 5 where 0 represents perfect health) < 1 (Appendix 2).
Key exclusion criteria (15 listed)
- Comorbidities precluding treatment with combination chemotherapy or per investigator discretion.
- Pregnancy or lactation.
- Medical or psychiatric illness that may compromise the patient's ability to tolerate the treatment or comply with the study requirements.
- Patients with another active cancer or history of another cancer in the last 3 years except those treated with curative intent such as skin cancer (other than melanoma), in situ breast or in situ cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 2 years.
- Allergy to PPI or inability to tolerate PPI.
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 |
|---|---|---|
| Omeprazole40mg of Omeprazole will be administered daily by mouth. | Drug | Observational, Standard Chemo + Omeprazole |
| CarboplatinCarboplatin will be administered over 30 minutes by continuous infusion. | Drug | Observational, Standard Chemo + Omeprazole, Standard Chemo + Placebo |
| 5FUAlso: 5-Fluorouracil, EfudexAdministered by infusion. | Drug | Observational, Standard Chemo + Omeprazole, Standard Chemo + Placebo |
| PaclitaxelAdministered by infusion. | Drug | Observational, Standard Chemo + Omeprazole, Standard Chemo + Placebo |
| PemetrexedAdministered by infusion. | Drug | Observational, Standard Chemo + Omeprazole, Standard Chemo + Placebo |
Primary outcome
Time to progression
Time frame: 6 months post treatment
The primary aim, progression-free survival, will be defined from start of treatment to date of first progression and will be tested using a Cox proportional hazard regression model with treatment arm as the only predictor.
2 secondary outcomes
Median overall survival
Time frame: 6 months post treatment
Proportion of patients that experience a response to treatment
Time frame: 6 months post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Francis Worden, M.D. principal investigator
University of Michigan Rogel 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 Omeprazole, Carboplatin and 5FU in people with Cancer of Head and Neck, run by University of Michigan Rogel Cancer Center 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 12 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: withdrawn, as of the sponsor's last update on 2 Dec 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to progression (time frame: 6 months post treatment). 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 2 Dec 2014.