Locally Advanced Pancreatic CancerPhase 1/2GEMOXELNCT00744640
Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma
A Phase 1/2 study testing gemcitabine, oxaliplatin, capecitabine in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.
Trial summary
Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- gemcitabine, oxaliplatin, capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesSwitzerland
- Study dates
- Oct 2005to Dec 2009
- Phase
- Phase 1/2
- 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
- Cytologically or histologically confirmed adenocarcinoma of the exocrine pancreas
- Disease non-resectable and locally advanced or metastatic
- Measurable disease or evaluable disease i.e. tumor marker CA19-9 at baseline ≥ 1.5 x upper limit of normal (ULN)
- Age >18 years
- Karnofsky performance status ≥ 60%
- Life expectancy of at least 3 months
- Written informed consent
- Willing and able to comply with the protocol for the duration of the study
Who cannot join
- Prior chemotherapy for pancreatic cancer
- Prior adjuvant radio- or radiochemotherapy for pancreatic cancer within 12 months of inclusion
- Known CNS metastases at the time of enrollment
- Neutrophil count ≤ 1.5 x109/l, platelet count ≤100 x109/l, hemoglobin ≤ 10g/dl
- Serum creatinine > 1.25 x ULN
- ASAT, ALAT and alkaline phosphatase > 2.5 ULN or > 5 ULN in the presence of liver metastasis, Bilirubin > 1.5 ULN (after treatment of obstructive jaundice eg. stent)
Show all 12Show fewer
- Pregnant or breast feeding women (women of childbearing potential must have a negative pregnancy test at baseline)
- Men and women of reproductive potential who are not using an effective method of contraception
- Clinically significant cardiac disease (NYHA III-IV) or myocardial infarction within the last 12 months
- Neurological disease with dys-/paraesthesias > grade 1 according to NCI CTC
- Any serious concomitant disorder incompatible with the trial (in the judgement of the investigator)
- Psychiatric disability thought to be clinically significant in the opinion of the investigator precluding informed consent or interfering with compliance
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Switzerland8 sites
St. Clara Hospital
Basel
University Hospital Basel
Basel
Cantonal Hospital Bruderholz
Bruderholz, Basel-Landschaft
Cantonal Hospital Liestal
Liestal, Basel-Landschaft
Cantonal Hospital Lucerne
Lucerne
City Hospital Triemli
Zurich
Oncocenter Hirslanden
Zurich
University Hospital
Zurich
About this study
Official title: Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study
Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.
Read the detailed description
Primary Objectives:
- Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination with gemcitabine and capecitabine (GEMOXEL) in patients with APC
- Phase II: to assess any anti-tumor activity of GEMOXEL in patients with APC
Secondary Objectives:
- to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC
Primary Endpoints:
- Phase I: Dose-limiting toxicity
- Phase II: Objective tumor response
Secondary Endpoints:
- Toxicity at MTD according to NCI CTC 3.0
- Progression-free survival and Overall Survival
- Being tested
- gemcitabine, oxaliplatin, capecitabine
- Keywords
- advanced pancreatic cancer, palliative chemotherapy, first-line therapy, capecitabine, oxaliplatin, gemcitabine, dose-finding study, Phase II
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine, oxaliplatin, capecitabineDrug
gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks
| Study group | Role | What they receive |
|---|---|---|
| single | Experimental | single arm study with triple combination chemotherapy Receives: Drug: gemcitabine, oxaliplatin, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 6 weeks
Secondary outcomes (1)
Progression-free survival and overall survival
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startOct 2005
- Primary completionFeb 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Cancer League, Roche Pharma AG, Sanofi
- Investigators
- Viviane Hess, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744640
- Sponsor's protocol ID
- EK-Nr. 92/05
- Other IDs
- 2005DR2296
- Acronym
- GEMOXEL
- Status last verified
- Jan 2010
- First submitted
- 29 Aug 2008
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study
- ClinicalTrials.gov ID
- NCT00744640
- Acronym / sponsor ID
- GEMOXEL / EK-Nr. 92/05
- Keywords
- advanced pancreatic cancer, palliative chemotherapy, first-line therapy, capecitabine, oxaliplatin, gemcitabine, dose-finding study, Phase II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Cancer League, Roche Pharma AG, Sanofi
- Study start
- Oct 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Sep 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.
Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.
Detailed description
Primary Objectives:
- Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination with gemcitabine and capecitabine (GEMOXEL) in patients with APC
- Phase II: to assess any anti-tumor activity of GEMOXEL in patients with APC
Secondary Objectives:
- to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC
Primary Endpoints:
- Phase I: Dose-limiting toxicity
- Phase II: Objective tumor response
Secondary Endpoints:
- Toxicity at MTD according to NCI CTC 3.0
- Progression-free survival and Overall Survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single | Experimental | Drug: gemcitabine, oxaliplatin, capecitabinesingle arm study with triple combination chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cytologically or histologically confirmed adenocarcinoma of the exocrine pancreas
- Disease non-resectable and locally advanced or metastatic
- Measurable disease or evaluable disease i.e. tumor marker CA19-9 at baseline ≥ 1.5 x upper limit of normal (ULN)
- Age >18 years
- Karnofsky performance status ≥ 60%
Key exclusion criteria (12 listed)
- Prior chemotherapy for pancreatic cancer
- Prior adjuvant radio- or radiochemotherapy for pancreatic cancer within 12 months of inclusion
- Known CNS metastases at the time of enrollment
- Neutrophil count ≤ 1.5 x109/l, platelet count ≤100 x109/l, hemoglobin ≤ 10g/dl
- Serum creatinine > 1.25 x ULN
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 |
|---|---|---|
| gemcitabine, oxaliplatin, capecitabinegemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks | Drug | single |
Primary outcome
Response rate
Time frame: 6 weeks
1 secondary outcome
Progression-free survival and overall survival
Time frame: 3 months
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 12 Jan 2010.
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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.
Viviane Hess, MD principal investigator
University Hospital, Basel, Switzerland
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing gemcitabine, oxaliplatin, capecitabine in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.
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 8 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: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. 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 combined 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.
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 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?
Response rate (time frame: 6 weeks). 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 12 Jan 2010.