Pancreatic AdenocarcinomaPhase 2NCT00728000
Phase II Study Of Neoadjuvant Chemotherapy In Borderline Resectable Pancreatic Adenocarcinoma
A Phase 2 study testing Gemcitabine, Oxaliplatin and Erlotinib in people with Pancreatic Adenocarcinoma, run by University of Cincinnati at 1 site in United States.
Trial summary
The goal of this study is to determine the effect of chemotherapy on decreasing the size of unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this study may provide information on how tumors behave when exposed to certain types of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine, Oxaliplatin and Erlotinib
- 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
- Aug 2008to Aug 2010
- 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
- Patients must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with endocrine tumors or lymphoma of the pancreas are ineligible.
- Patients must have locally advanced disease that is considered to be "borderline" surgically resectable (see Section 4.0). Patients with metastatic disease or grossly resectable disease on presentation are ineligible.
- Patients must have measurable disease prior to starting this study. Patients with primarily non-measurable disease, including lesions to small to be characterized, effusions, ascites, diffuse bone disease, diffuse skin disease, leptomeningeal disease, lymphangitis, pneumonitis or disease measured by indirect or biochemical means, are not eligible. Testing for measurable disease must have been completed 28 days prior to registration.
- Patients must consent to utilization of tissue for research in this protocol. Tissue will be evaluated via immunohistochemical staining for deoxycytidine kinase, ERCC-1 and ERCC-2 (XPD). Patients may be asked if they are willing to allow their tissue to be used for future studies that are not defined in this protocol. Disallowing the use of tissue for future studies does not limit eligibility in this protocol.
- Patients must fulfill the required initial laboratory data to be obtained within 28 days prior to registration: AGC ≥ 1,500cells/μL, Platelet ≥ 100,000cells/μL, Hgb > 8.0 g/dl, Bilirubin ≤ 2.0 X IULN, Serum Creatinine ≤ 2.0mg/dL, AST(SGOT) ≤ 2.5x IULN, ALT(SGPT) ≤ 2.5x IULN, CA19-9 (any value),
- Patients must have an ECOG/Zubrod performance status of 0-2.
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- Patients must be able to read and understand English in order to participate in this study, or have a certified translator present.
- Due to the potentially harmful effects of chemotherapy on a developing fetus, patients who are pregnant are planning to become pregnant, or who are lactating should not participate in this study.
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- All patients must be informed of the investigational nature of this study and must sign, date and give written consent in accordance with institutional and federal guidelines.
- All patients must be18 years of age or older to participate.
Who cannot join
- Patients with known brain metastases are ineligible. Brain imaging studies are not required for eligible patients with no neurologic signs or symptoms. If brain imaging studies are performed, they must be negative for disease.
- Patients who have had prior surgery for their pancreatic carcinoma are not eligible for this study. This does not include patients who have had cytologic brushing, fine needle aspiration or core biopsy of their tumor for diagnostic purposes.
- Patients must not have received prior chemotherapy, radiotherapy, chemoradiotherapy, surgery, immunotherapy or hormonal therapy for pancreatic cancer.
- Patients must not have received prior erlotinib or other therapies that target EGFR. Patients must not have received prior tyrosine kinase inhibitors.
- Have a significant history of uncontrolled cardiac disease including uncontrolled hypertension, unstable angina or uncontrolled congestive heart failure.
- Have a significant history of intersitital lung disease
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- Have a significant history of peripheral neuropathy (grade must be <1) or mononeuropathy multiplex.
- Have temperature >101.30 F or active infection
- No other history of malignancy is allowed except for the following:
- adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- There must be no other plans for the patient to receive concurrent chemotherapy, radiotherapy, chemoradiotherapy, surgery, immunotherapy or hormonal therapy for the treatment of their cancer while on protocol.
- Due to the undetermined effect of chemotherapy in patients with HIV infection and the potential for serious interaction with anti-HIV medications, patients who are known to be infected with HIV are not eligible for this study. An HIV test is not required to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma
The goal of this study is to determine the effect of chemotherapy on decreasing the size of unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this study may provide information on how tumors behave when exposed to certain types of chemotherapy.
Read the detailed description
Although surgery is the only curative modality for pancreatic adenocarcinoma, the majority of patients (~80%)are unresectable at presentation. The use of a multimodality approach may be a crucial method to improve the dismal survival rate of patients with pancreatic cancer. A logical tactic is to use neoadjuvant cytotoxic agents and targeted drugs to facilitate resectability.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine, Oxaliplatin, Erlotinib
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar®
Gemcitabine 1000mg/m2 IV on day 1 and day 15 over 30mins.
OxaliplatinDrug
Also called Eloxatin
100mg/m2 IV on days 1 and 15 given over 120 mins.
ErlotinibDrug
Also called Tarceva
100mg/day PO on days 1-14 and 15-28
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy regimen | Experimental | Gemcitabine and oxaliplatin are given intravenously (into the vein) every 2 weeks. Erlotinib is a pill that is taken by mouth daily. Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is a dichotomous variable evaluating the # of patients who obtain an RO resection versus the number of patients that do not obtain an RO resection plus the number of patients who are not resectable.
Measured: 9-10 months
Secondary outcomes (1)
DFS, PFS, OS and TD will be observed on each patient and censored at the end of the study. Measurements of toxicity are categorical variables. All numerical variables will be summarized by mean +- standard deviation (STD) and/or median (range)
Measured: 9-10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
- Study completionAug 2010 (estimated)
Why it stopped: study withdrawn due to lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Leslie Oleksowicz, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728000
- Sponsor's protocol ID
- OX-06-030
- Other IDs
- OX-06-030
- Status last verified
- Nov 2019
- First submitted
- 31 Jul 2008
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00728000
- Acronym / sponsor ID
- OX-06-030
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study withdrawn due to lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 5 Aug 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 goal of this study is to determine the effect of chemotherapy on decreasing the size of unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this study may provide information on how tumors behave when exposed to certain types of chemotherapy.
Detailed description
Although surgery is the only curative modality for pancreatic adenocarcinoma, the majority of patients (~80%)are unresectable at presentation. The use of a multimodality approach may be a crucial method to improve the dismal survival rate of patients with pancreatic cancer. A logical tactic is to use neoadjuvant cytotoxic agents and targeted drugs to facilitate resectability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy regimen | Experimental | Drug: Gemcitabine, Drug: Oxaliplatin, Drug: ErlotinibGemcitabine and oxaliplatin are given intravenously (into the vein) every 2 weeks. Erlotinib is a pill that is taken by mouth daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have a histologic or cytologic diagnosis of pancreatic adenocarcinoma. Patients with endocrine tumors or lymphoma of the pancreas are ineligible.
- Patients must have locally advanced disease that is considered to be "borderline" surgically resectable (see Section 4.0). Patients with metastatic disease or grossly resectable disease on presentation are ineligible.
- Patients must have measurable disease prior to starting this study. Patients with primarily non-measurable disease, including lesions to small to be characterized, effusions, ascites, diffuse bone disease, diffuse skin disease, leptomeningeal disease, lymphangitis, pneumonitis or disease measured by indirect or biochemical means, are not eligible. Testing for measurable disease must have been completed 28 days prior to registration.
- Patients must consent to utilization of tissue for research in this protocol. Tissue will be evaluated via immunohistochemical staining for deoxycytidine kinase, ERCC-1 and ERCC-2 (XPD). Patients may be asked if they are willing to allow their tissue to be used for future studies that are not defined in this protocol. Disallowing the use of tissue for future studies does not limit eligibility in this protocol.
- Patients must fulfill the required initial laboratory data to be obtained within 28 days prior to registration: AGC ≥ 1,500cells/μL, Platelet ≥ 100,000cells/μL, Hgb > 8.0 g/dl, Bilirubin ≤ 2.0 X IULN, Serum Creatinine ≤ 2.0mg/dL, AST(SGOT) ≤ 2.5x IULN, ALT(SGPT) ≤ 2.5x IULN, CA19-9 (any value),
Key exclusion criteria (12 listed)
- Patients with known brain metastases are ineligible. Brain imaging studies are not required for eligible patients with no neurologic signs or symptoms. If brain imaging studies are performed, they must be negative for disease.
- Patients who have had prior surgery for their pancreatic carcinoma are not eligible for this study. This does not include patients who have had cytologic brushing, fine needle aspiration or core biopsy of their tumor for diagnostic purposes.
- Patients must not have received prior chemotherapy, radiotherapy, chemoradiotherapy, surgery, immunotherapy or hormonal therapy for pancreatic cancer.
- Patients must not have received prior erlotinib or other therapies that target EGFR. Patients must not have received prior tyrosine kinase inhibitors.
- Have a significant history of uncontrolled cardiac disease including uncontrolled hypertension, unstable angina or uncontrolled congestive heart failure.
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 |
|---|---|---|
| GemcitabineAlso: Gemzar®Gemcitabine 1000mg/m2 IV on day 1 and day 15 over 30mins. | Drug | chemotherapy regimen |
| OxaliplatinAlso: Eloxatin100mg/m2 IV on days 1 and 15 given over 120 mins. | Drug | chemotherapy regimen |
| ErlotinibAlso: Tarceva100mg/day PO on days 1-14 and 15-28 | Drug | chemotherapy regimen |
Primary outcome
The primary endpoint is a dichotomous variable evaluating the # of patients who obtain an RO resection versus the number of patients that do not obtain an RO resection plus the number of patients who are not resectable.
Time frame: 9-10 months
1 secondary outcome
DFS, PFS, OS and TD will be observed on each patient and censored at the end of the study. Measurements of toxicity are categorical variables. All numerical variables will be summarized by mean +- standard deviation (STD) and/or median (range)
Time frame: 9-10 months
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 25 Nov 2019.
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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.
Leslie Oleksowicz, MD principal investigator
University of Cincinnati
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 Gemcitabine, Oxaliplatin and Erlotinib in people with Pancreatic Adenocarcinoma, run by University of Cincinnati 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 12 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 25 Nov 2019. 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?
The primary endpoint is a dichotomous variable evaluating the # of patients who obtain an RO resection versus the number of patients that do not obtain an RO resection plus the number of patients who are not resectable. (time frame: 9-10 months). 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 25 Nov 2019.