CancerPhase 1NCT00707278
Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
A Phase 1 study testing Radiation Therapy, Capecitabine and Oxaliplatin in people with Cancer and Pancreas, run by University of Utah at 1 site in United States.
Trial summary
The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgically unresectable. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Radiation Therapy, Capecitabine and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 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
Patient Selection Criteria
- Pathologically confirmed adenocarcinoma of the pancreas.
- No distant metastases (no metastases beyond regional lymph nodes).
- Deemed surgically unresectable by a surgical oncologist due to hepatic artery, celiac axis, superior mesenteric artery, superior mesenteric vein, portal vein, aorta, inferior vena cava, and/or rib/vertebral body involvement as defined by CT/MRI scan and/or endoscopic ultrasound (EUS).
- No malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
- No previous chemotherapy for pancreatic cancer.
- No prior irradiation to the planned field.
- Zubrod performance status 0-1.
- Granulocytes > 1,800, platelets > 100,000/ul, bilirubin < 2.0 mg/dL, ALT < 3x upper limits of normal, creatinine < 3.0 mg/dL.
- No significant infection or other coexistent medical condition.
- No pregnant or lactating women.
- Age > 18 years old.
- Signed study-specific consent form prior to registration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgically unresectable. Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population.
Secondary objectives of the study are to determine the tumor response rate, survival rate, local control rate and the rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery and to determine the rate at which patients with unresectable disease become resectable.
Read the detailed description
Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population.
Three dose levels are planned, as shown in the "Dose Escalation" table below. Three patients are planned at each level. When 3 patients have completed an entire chemoradiation course and are monitored for at least 2 weeks after the end of treatment without the occurrence of dose limiting toxicities (DLTs), then the next 3 patients will be treated at the next highest dose level. If one of the first three patients treated at any given dose level experiences a DLT, three further patients will be treated at that level. If only one in six patients at a given level experiences a DLT, escalation can proceed. If two or more of three to six patients at the lowest administered dose level experience DLTs, then the MTD is below the lowest administered dose, but no specific MTD will be defined. If two or more of three to six patients at a higher dose level experiences DLTs, the dose preceding the lowest dose level satisfying this criterion will be declared the MTD. If all the dose levels are exhausted without two or more of three to six patients experiencing DLTs, then the MTD is higher than the maximum administered dose, but no specific MTD will be defined. If MTD is reached at a given dose level, then additional patients can be accrued to the next lowest dose level, such that up to six patients can be accrued to the dose level below MTD. Because three dose levels are planned, with 3 to 6 patients enrolled in each dose level, a minimum of 9 and a maximum of 18 patients are required for trial completion.
- Being tested
- Radiation Therapy, Capecitabine, Oxaliplatin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Radiation therapy will be delivered concurrently with capecitabine and oxaliplatin chemotherapy Radiation therapy dose will be 50.4 Gy (1.8 Gy per day, 5 days per week, for 28 treatments).
CapecitabineDrug
Also called Chemotherapy
Capecitabine Dose (given twice daily concurrent with radiation therapy) Dose level 1: 400 mg/m2 Dose level 2:600 mg/m2 Dose level 3:600 mg/m2
OxaliplatinDrug
Also called chemotherapy
Oxaliplatin Dose (given weekly concurrent with radiation therapy) Dose level 1: 50 mg/m2 Dose level 2: 50 mg/m2 Dose level 3: 60 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All participants enrolled. Receives: Radiation: Radiation Therapy; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
Measured: September 2012
Secondary outcomes (1)
To determine tumor response rate, survival rate, local control rate and rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
Measured: September 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startSep 2005
- Primary completionAug 2011
- Study completionAug 2011
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.
- More trials run by University of UtahThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Shrieve, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707278
- Sponsor's protocol ID
- HCI13633
- Status last verified
- Oct 2014
- First submitted
- 26 Jun 2008
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase I Study of Radiation Therapy and Concurrent Capecitabine and Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00707278
- Acronym / sponsor ID
- HCI13633
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Jun 2008 (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 study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgically unresectable. Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population.
Secondary objectives of the study are to determine the tumor response rate, survival rate, local control rate and the rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery and to determine the rate at which patients with unresectable disease become resectable.
Detailed description
Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population.
Three dose levels are planned, as shown in the "Dose Escalation" table below. Three patients are planned at each level. When 3 patients have completed an entire chemoradiation course and are monitored for at least 2 weeks after the end of treatment without the occurrence of dose limiting toxicities (DLTs), then the next 3 patients will be treated at the next highest dose level. If one of the first three patients treated at any given dose level experiences a DLT, three further patients will be treated at that level. If only one in six patients at a given level experiences a DLT, escalation can proceed. If two or more of three to six patients at the lowest administered dose level experience DLTs, then the MTD is below the lowest administered dose, but no specific MTD will be defined. If two or more of three to six patients at a higher dose level experiences DLTs, the dose preceding the lowest dose level satisfying this criterion will be declared the MTD. If all the dose levels are exhausted without two or more of three to six patients experiencing DLTs, then the MTD is higher than the maximum administered dose, but no specific MTD will be defined. If MTD is reached at a given dose level, then additional patients can be accrued to the next lowest dose level, such that up to six patients can be accrued to the dose level below MTD. Because three dose levels are planned, with 3 to 6 patients enrolled in each dose level, a minimum of 9 and a maximum of 18 patients are required for trial completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Radiation: Radiation Therapy, Drug: Capecitabine, Drug: OxaliplatinAll participants enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Radiation TherapyRadiation therapy will be delivered concurrently with capecitabine and oxaliplatin chemotherapy Radiation therapy dose will be 50.4 Gy (1.8 Gy per day, 5 days per week, for 28 treatments). | Radiation | All patients |
| CapecitabineAlso: ChemotherapyCapecitabine Dose (given twice daily concurrent with radiation therapy) Dose level 1: 400 mg/m2 Dose level 2:600 mg/m2 Dose level 3:600 mg/m2 | Drug | All patients |
| OxaliplatinAlso: chemotherapyOxaliplatin Dose (given weekly concurrent with radiation therapy) Dose level 1: 50 mg/m2 Dose level 2: 50 mg/m2 Dose level 3: 60 mg/m2 | Drug | All patients |
Primary outcome
To determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
Time frame: September 2012
1 secondary outcome
To determine tumor response rate, survival rate, local control rate and rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma.
Time frame: September 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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.
Dennis Shrieve, MD principal investigator
Huntsman Cancer Institute
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 Radiation Therapy, Capecitabine and Oxaliplatin in people with Cancer and Pancreas, run by University of Utah 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?
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: finished, as of the sponsor's last update on 31 Oct 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in patients with locally advanced pancreas adenocarcinoma. (time frame: September 2012). 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 Oct 2014.