CancerPhase 1NCT02078089
Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain
A Phase 1 study testing Morphine and Oxcarbazepine in people with Cancer, run by Costantine Albany at 2 sites in United States.
Trial summary
This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the safety and toxicity of the combination of Oxcarbazepine plus morphine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Morphine and Oxcarbazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2014to 11 Dec 2014
- 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
- Written informed consent and HIPAA authorization for release of personal health information.
- •≥ 18 years old at the time of informed consent
- Patients with histologically confirmed diagnosis of cancer NOTE: Patients with active cancer or post treatment are allowed on the study.
- Patients must be receiving stable or increasing doses of morphine for 1-2 weeks prior to registration for protocol therapy.
- NOTE: Switching patient from current pain regimen to morphine equivalent for at least 1-2 weeks prior to registration for protocol therapy is required.
- Requiring greater than or equal to 180 mg of morphine per day. See Appendix 1 for Morphine Conversion Calculator.
Show all 22Show fewer
- Inadequately controlled pain even with the use of morphine (VAS score >5) See Appendix 8
- Rescue pain medications are allowed this may include the use of NSAIDS or Tylenol as well as morphine IR.
- ECOG Performance Status of 0-2
- Ability to swallow and tolerate oral tablets.
- Patients getting radiation therapy are allowed at the discretion of the treating physician.
- Females of childbearing potential must have a negative pregnancy test NOTE: Females are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (> 12 months since last menses).
- NOTE: Females using hormonal contraceptives should be switched to non-hormonal forms of contraception.
- The following laboratory values must be obtained. Patient with aplastic anemia will be excluded.
- White blood cell count (WBC) ≥ 3.0 K/mm3
- Absolute neutrophil count ≥ 1.5 K/mm3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 75 K/mm3
- Creatinine ≤ 1.5 mg/dl
- Bilirubin ≤ 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN
Who cannot join
- Active central nervous system (CNS) metastases. Patients with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician.
- NOTE: Patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- Concurrent use of adjuvant medication such as but not limited to: gabapentin, pregabalin or duloxetine etc.
- NOTE: Patients on gabapentin or pregabalin can be considered if they can be tapered off before enrolling on the study.
- Treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- Patient with rapidly escalating pain that require hospitalization or an intravenous opioid therapy
Show all 15Show fewer
- Concurrent participation in a clinical trial which involves another investigational agent.
- Concurrent use of medications that are strong CYP3A4 inhibitors within 14 days prior to registration for protocol therapy as Oxcarbazepine is strong CYP3A4 inducer. See Appendix 7.
- NOTE: Concurrent use of other CYP3A4 inhibitors may be allowed at the discretion of the treating physician or principal investigator.
- Allergic reaction to carbamazepine or oxcarbazepine (HLA-B1502)
- Allergy or other contraindication to morphine sulphate
- Opiate-induced uncontrolled constipation or bowel obstruction
- Patient who lives alone.
- Female who is pregnant or breastfeeding
- Patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana Univeristy Health Hospital
Indianapolis, Indiana, 46202
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Phase Ib Study of Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain
This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary endpoints are improving pain control, reduce morphine use and improve the quality of life.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Morphine Sulfate
Morphine will be given to patients as part of their standard care
OxcarbazepineDrug
Also called Tileptal
Can be taken with or without food at the same time as morphine. Morphine will be provided to patients free of charge.
| Study group | Role | What they receive |
|---|---|---|
| Oxcarbazepine and Morphine | Other | Patients must be on stable or increasing doses of greater than or equal to 180 mg of morphine sulfate per day. Morphine is taken orally for 42 days.
In addition to Morphine, patients will also receive oral Oxcarbazepine 150 mg, every 12 hours, for 2 weeks, then increase the dose to 300 mg, every 12 hours, for 2 weeks and then increase the dose to 450 mg, every 12 hours, for the final 2 weeks. Patients will take oral tablets of oxcarbazepine for a total of 42 days. Receives: Drug: Morphine; Drug: Oxcarbazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events as a measure of safety and toxicity
Evaluate the safety and toxicity of oxcarbazepine in combination with morphine
Measured: 1 year
Secondary outcomes (3)
Changes in Pain control
Evaluate changes in pain control after adding oxcarbazepine to morphine
Measured: 1 year
Changes in Consumption
Evaluate changes morphine consumption after adding oxcarbazepine to morphine
Measured: 1 year
Changes in Quality of Life
Evaluate changes in Quality of Life after adding oxcarbazepine to morphine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study start6 Mar 2014
- Primary completion11 Dec 2014
- Study completion11 Dec 2014
Why it stopped: Poor Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Costantine Albany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Costantine Albany, Indiana University
- Investigators
- Costantine Albany, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078089
- Sponsor's protocol ID
- IUCRO-0453
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2014
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain
- ClinicalTrials.gov ID
- NCT02078089
- Acronym / sponsor ID
- IUCRO-0453
- Conditions
- Cancer
- Keywords
- Refractory cancer pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Costantine AlbanyUniversity, hospital or other
- Study start
- 6 Mar 2014 (actual)
- Primary completion
- 11 Dec 2014 (actual)
- Study completion
- 11 Dec 2014 (actual)
- First posted
- 5 Mar 2014 (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.
This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary endpoints are improving pain control, reduce morphine use and improve the quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxcarbazepine and Morphine | Other | Drug: Morphine, Drug: OxcarbazepinePatients must be on stable or increasing doses of greater than or equal to 180 mg of morphine sulfate per day. Morphine is taken orally for 42 days. In addition to Morphine, patients will also receive oral Oxcarbazepine 150 mg, every 12 hours, for 2 weeks, then increase the dose to 300 mg, every 12 hours, for 2 weeks and then increase the dose to 450 mg, every 12 hours, for the final 2 weeks. Patients will take oral tablets of oxcarbazepine for a total of 42 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Written informed consent and HIPAA authorization for release of personal health information.
- •≥ 18 years old at the time of informed consent
- Patients with histologically confirmed diagnosis of cancer NOTE: Patients with active cancer or post treatment are allowed on the study.
- Patients must be receiving stable or increasing doses of morphine for 1-2 weeks prior to registration for protocol therapy.
- NOTE: Switching patient from current pain regimen to morphine equivalent for at least 1-2 weeks prior to registration for protocol therapy is required.
Key exclusion criteria (15 listed)
- Active central nervous system (CNS) metastases. Patients with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician.
- NOTE: Patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- Concurrent use of adjuvant medication such as but not limited to: gabapentin, pregabalin or duloxetine etc.
- NOTE: Patients on gabapentin or pregabalin can be considered if they can be tapered off before enrolling on the study.
- Treatment with any investigational agent within 30 days prior to registration for protocol therapy.
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 |
|---|---|---|
| MorphineAlso: Morphine SulfateMorphine will be given to patients as part of their standard care | Drug | Oxcarbazepine and Morphine |
| OxcarbazepineAlso: TileptalCan be taken with or without food at the same time as morphine. Morphine will be provided to patients free of charge. | Drug | Oxcarbazepine and Morphine |
Primary outcome
Number of patients with adverse events as a measure of safety and toxicity
Time frame: 1 year
Evaluate the safety and toxicity of oxcarbazepine in combination with morphine
3 secondary outcomes
Changes in Pain control
Time frame: 1 year
Changes in Consumption
Time frame: 1 year
Changes in Quality of Life
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Poor Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Costantine Albany, M.D. principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Morphine and Oxcarbazepine in people with Cancer, run by Costantine Albany at 2 sites 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 22 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: stopped early, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Poor Accrual). 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?
Number of patients with adverse events as a measure of safety and toxicity (time frame: 1 year). 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 31 Jan 2017.