Metastatic Pancreatic CancerPhase 1BrUOG-PA205NCT00439179
A Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema
A Phase 1 study testing cohort 1, cohort 2 and cohort 3 in people with Metastatic Pancreatic Cancer, run by Brown University at 1 site in United States.
Trial summary
A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- cohort 1, cohort 2 and cohort 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2007
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 are required to have histologically or pathologically confirmed, metastatic or locally advanced adenocarcinoma of the pancreas or biliary tree
- No prior systemic chemotherapy for locally advanced or metastatic pancreaticobiliary cancer. No prior EGFR inhibitors.
- ECOG performance status 0-2 retain ability to swallow oral medications
- Age > 18, non pregnant. Because no dosing or adverse event data are currently available on the use of GW572016 in patients <18 years of age, children are excluded from this study.
- The effects of GW572016 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female is eligible to enter and participate in the study if she is of:
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- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
- Has had a hysterectomy,
- Has had a bilateral oophorectomy (ovariectomy),
- Has had a bilateral tubal ligation, or
- Is post-menopausal(a demonstration of total cessation of menses for ³1 year).
- Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following:
- Intrauterine Device (IUD),
- Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
- Complete abstinence from sexual intercourse for two weeks before exposure to investigational products, throughout the clinical trial, and for at least one week after the last dose of investigational product.
- Double barrier contraception (condom with spermicidal jelly, foam, suppository, or film; diaphragm with spermicide; or male condom and diaphragm)
- Adequate hematologic function: ANC≥1500/ul,platelets≥100,000/ul,hemoglobin 8
- Adequate hepatic function with total bilirubin ≤ 1.5mg/dL and ALT or AST ≤ 2x ULN. (Patients with liver metastases may have AST/ALT less than or equal to 5x upper limit of normal). Patients with elevated bilirubin secondary to biliary obstruction that have subsequently been stented may enter the protocol with a bilirubin of < 2.0 as long as the bilirubin is falling.
- Adequate renal function: (creatinine ≤1.5mg/dL or estimated creatinine clearance greater than 60ml/min calculated by the Cockcroft Formula).
- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan. Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution.
- No peripheral neuropathy for patients who receive oxaliplatin.
- Life expectancy of at least 12 weeks
- Signed informed consent
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Prior treatment with GW572016 or any EGFR targeting therapies.
- Prior treatment with systemic chemotherapy for metastatic pancreaticobiliary cancer.
- Evidence of brain metastases or leptomeningeal disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known contraindications to the use of oxaliplatin or gemcitabine.
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- History of allergy to platinum compounds in patients receiving oxaliplatin. Amendment #2 4/28/05
- The subject has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GW572016
- Participation in any investigational study within 28 days prior to study enrolment
- Any major surgery (insertion of a vascular access device is not considered a major surgery), hormonal therapy (other than replacement), chemotherapy or radiotherapy within the last 4 weeks and/or not recovered from prior therapy within the last 4 weeks and/or not recovered from prior therapy.
- Pregnant or lactating females are excluded from this study because GW572016 is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GW572016, breastfeeding should be discontinued if the mother is treated with GW572016.
- Malabsorption syndrome disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption of GW572016.
- Any unresolved bowel obstruction.
- The patient has inadequate venous access in the clinical judgment of the investigator or designated clinical staff.
- The patient is taking any medication on the prohibited medications list in Section 10.2 Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR. If medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with GW572016 is not expected.
- Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University Oncology Research Group
Providence, Rhode Island, 02903
About this study
Official title: BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556
A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema
Read the detailed description
The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety at the final dose level in both Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated on this study.
Trial finished and no further data will be collected.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- cohort 1, cohort 2, cohort 3, cohort 4
- 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.
cohort 1Drug
Weekly gem + GW572016, 1000mg/day (combination)
cohort 2Drug
Weekly gem + GW572016, 1500 mg/day (combination)
cohort 3Drug
GEMOX + GW572016 1000 mg/day (combination)
cohort 4Drug
GEMOX + GW572016 1500 mg/day (combination)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Weekly gem + GW572016, 1000mg/day (combination) Receives: Drug: cohort 1 |
| Cohort 2 | Experimental | Weekly gem + GW572016, 1500 mg/day (combination) Receives: Drug: cohort 2 |
| cohort 3 | Experimental | GEMOX + GW572016 1000 mg/day (combination) Receives: Drug: cohort 3 |
| cohort 4 | Experimental | GEMOX + GW572016 1500 mg/day (combination) Receives: Drug: cohort 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity (Number of Patients Who Experiened DLTs)
To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs
Measured: until death, approximately 2 years
Secondary outcomes (1)
Number of Patients Who Experienced a Partial Response
To assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.
Measured: every two months until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, howard safran, Brown University
- Investigators
- howard Safran, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439179
- Sponsor's protocol ID
- BrUOG-PA-205
- Acronym
- BrUOG-PA205
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2007
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG-PA-205 A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema GSK Study ProtocolGSK #103556
- ClinicalTrials.gov ID
- NCT00439179
- Acronym / sponsor ID
- BrUOG-PA205 / BrUOG-PA-205
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Posted 5 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I Trial of GW572016, Gemcitabine and Oxaliplatin for Metastatic Pancreaticobiliary Cancer Schema
Detailed description
The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the combination of gemcitabine and oxaliplatin. Three to six patients will be treated at each dose level to assess toxicity. To better assess the safety at the final dose level in both Stage I and Stage II, the number of patients in the cohort at the Maximum Tolerated Dose for both Stages will be expanded to 10. Therefore approximately 34-37 patients will be treated on this study.
Trial finished and no further data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: cohort 1Weekly gem + GW572016, 1000mg/day (combination) |
| Cohort 2 | Experimental | Drug: cohort 2Weekly gem + GW572016, 1500 mg/day (combination) |
| cohort 3 | Experimental | Drug: cohort 3GEMOX + GW572016 1000 mg/day (combination) |
| cohort 4 | Experimental | Drug: cohort 4GEMOX + GW572016 1500 mg/day (combination) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients are required to have histologically or pathologically confirmed, metastatic or locally advanced adenocarcinoma of the pancreas or biliary tree
- No prior systemic chemotherapy for locally advanced or metastatic pancreaticobiliary cancer. No prior EGFR inhibitors.
- ECOG performance status 0-2 retain ability to swallow oral medications
- Age > 18, non pregnant. Because no dosing or adverse event data are currently available on the use of GW572016 in patients <18 years of age, children are excluded from this study.
- The effects of GW572016 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (17 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Prior treatment with GW572016 or any EGFR targeting therapies.
- Prior treatment with systemic chemotherapy for metastatic pancreaticobiliary cancer.
- Evidence of brain metastases or leptomeningeal disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| cohort 1Weekly gem + GW572016, 1000mg/day (combination) | Drug | Cohort 1 |
| cohort 2Weekly gem + GW572016, 1500 mg/day (combination) | Drug | Cohort 2 |
| cohort 3GEMOX + GW572016 1000 mg/day (combination) | Drug | cohort 3 |
| cohort 4GEMOX + GW572016 1500 mg/day (combination) | Drug | cohort 4 |
Primary outcome
Toxicity (Number of Patients Who Experiened DLTs)
Time frame: until death, approximately 2 years
To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs
1 secondary outcome
Number of Patients Who Experienced a Partial Response
Time frame: every two months until progression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
howard Safran, MD principal investigator
Brown University
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 cohort 1, cohort 2 and cohort 3 in people with Metastatic Pancreatic Cancer, run by Brown University 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 23 inclusion and 17 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: finished, as of the sponsor's last update on 17 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 5 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Toxicity (Number of Patients Who Experiened DLTs) (time frame: until death, approximately 2 years). 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 17 Feb 2020.