A Phase II Trial of Proton Pump Inhibitors With Chemotherapy in Patients With Metastatic Head and Neck Cancer
NCT ID: NCT02013453
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Observational
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.
Omeprazole
40mg of Omeprazole will be administered daily by mouth.
Carboplatin
Carboplatin will be administered over 30 minutes by continuous infusion.
5FU
Administered by infusion.
Paclitaxel
Administered by infusion.
Pemetrexed
Administered by infusion.
Standard Chemo + Placebo
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.
Carboplatin
Carboplatin will be administered over 30 minutes by continuous infusion.
5FU
Administered by infusion.
Paclitaxel
Administered by infusion.
Pemetrexed
Administered by infusion.
Standard Chemo + Omeprazole
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.
Omeprazole
40mg of Omeprazole will be administered daily by mouth.
Carboplatin
Carboplatin will be administered over 30 minutes by continuous infusion.
5FU
Administered by infusion.
Paclitaxel
Administered by infusion.
Pemetrexed
Administered by infusion.
Interventions
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Omeprazole
40mg of Omeprazole will be administered daily by mouth.
Carboplatin
Carboplatin will be administered over 30 minutes by continuous infusion.
5FU
Administered by infusion.
Paclitaxel
Administered by infusion.
Pemetrexed
Administered by infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
a. 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).
* 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).
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Francis Worden, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00074951
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2013.046
Identifier Type: -
Identifier Source: org_study_id