Pancreas NeoplasmsPhase 2NCT00690300
Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer
A Phase 2 study testing Docetaxel and Oxaliplatin in people with Pancreas Neoplasms, run by University of Ulm at 5 sites in Germany.
Trial summary
The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasms
- What is being tested?
- Docetaxel and Oxaliplatin
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 5 sitesGermany
- Study dates
- Jan 2008to Dec 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
- Dated and signed informed concent
- Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV)
- Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy
- Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity
- Age >= 18 years
- Karnofsky index > 60%
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- Expected live span > 12 weeks
- Sufficient bone marrow reserve: Granulocytes >= 1.5 x 109/L and Platelets >= 100 x 109/L and Hemoglobin >= 9 g/L
- Serum Bilirubin < 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed)
- AST/ALT < 2.5 x upper normal limit
Who cannot join
- Every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. Inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible
- Pregnancy or lactation
- Patients able to reproduce that do not adhere to strict contraception
- Presence of brain metastasis
- Severe, uncontrolled infection
- Preexisting peripheral neuropathy > grade I
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- Preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia
- Justified disbelief in the compliance of the patient
- Parallel participation in another clinical trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Städtische Kliniken Esslingen
Esslingen am Neckar, Baden-Wurttemberg, 73730
Michael Geissler, Prof. Dr., 49-711-3103-2451, m.geissler@kliniken-es.de
Michael Geissler, Prof. Dr.
- Recruiting
Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle
Halle, 06097
Thomas Seufferlein, Prof. Dr., + 49 345 557 2661, thomas.seufferlein@medizin.uni-halle.de
Thomas Seufferlein, Prof. Dr.
- Recruiting
Universitätsklinikum Giessen und Marburg GmbH
Marburg, Hesse, 35043
Heiko Fensterer, Dr., 49-6421-286-6460, heiko.fensterer@med.uni-marburg.de
Heiko Fensterer, Dr.
- Recruiting
Klinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, 73557
Holger Hebart, Prof. Dr., holger.hebart@klinikum.sgd.de
Holger Hebart, Prof. Dr.
- Recruiting
Universitätsklinikum Ulm Klinik für Innere Medizin I
Ulm, Baden-Wurttemberg, 89081
Goetz von Wichert, PD Dr., 49-731-500-44748, goetz.wichert@uniklinik-ulm.de
Jochen Klaus, Dr., 49-731-500-44727, jochen.klaus@uniklinik-ulm.de
About this study
Official title: Phase II Study: Docetaxel Plus Oxaliplatin as Second-line Therapy in Patients With Advanced Metastatic Pancreatic Cancer
The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.
Read the detailed description
For years Fluorouracil was the established treatment for pancreatic cancer with median survival times up to 8 months. Since 1997 Gemcitabine is also a standard therapy with in comparison to Fluorouracil a significant better clinical benefit.
But after progression of the disease under a palliative first-line therapy there is no established second line therapy for pancreatic cancer.
So the purpose of this study is to test the combination of Oxaliplatin and Docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy to get a reasonable second line concept.
- Conditions
- Pancreas Neoplasms
- Being tested
- Docetaxel, Oxaliplatin
- Keywords
- adenocarcinoma of the pancreas, pancreatic cancer, pancreas carcinoma, advanced pancreatic cancer, metastatic pancreatic cancer, second line, palliative, Oxaliplatin, Docetaxel, Taxotere, Eloxatin, Cancer of pancreas, Pancreas 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.
DocetaxelDrug
Also called Taxotere
75 mg/m2 IV on day 1 of each 22 day cycle
OxaliplatinDrug
Also called Eloxatin
80 mg/m2 IV on day 2 of each 22 day cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response
Measured: 12/2009 and end of the study 12/2010
Secondary outcomes (5)
progression free survival
Measured: 12/2009 and end of study 12/2010
overall survival
Measured: 12/2009 and end of study 12/2010
Questionnaire for quality of life
Measured: every three weeks
Questionnaire for clinical Benefit
Measured: every week
toxicity / safety
all adverse events will be documented every week with their correlation to Oxaliplatin and Docetaxel
Measured: every week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Seufferlein, Prof. Dr., Principal investigator, Universitätsklinikum Halle / Klinik für Innere Medizin I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690300
- Sponsor's protocol ID
- I1-GOA-1
- Other IDs
- EudraCT 2005-004236-40
- Status last verified
- Jan 2010
- First submitted
- 2 Jun 2008
- Last updated
- 3 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ettrich TJ, Perkhofer L, von Wichert G, Gress TM, Michl P, Hebart HF, Buchner-Steudel P, Geissler M, Muche R, Danner B, Kachele V, Berger AW, Guthle M, Seufferlein T. DocOx (AIO-PK0106): a phase II trial of docetaxel and oxaliplatin as a second line systemic therapy in patients with advanced pancreatic ductal adenocarcinoma. BMC Cancer. 2016 Jan 15;16:21. doi: 10.1186/s12885-016-2052-4.
PubMed 26772812
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Docetaxel Plus Oxaliplatin as Second-line Therapy in Patients With Advanced Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00690300
- Acronym / sponsor ID
- I1-GOA-1
- Conditions
- Pancreas Neoplasms
- Keywords
- adenocarcinoma of the pancreas, pancreatic cancer, pancreas carcinoma, advanced pancreatic cancer, metastatic pancreatic cancer, second line, palliative, Oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 4 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 purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.
Detailed description
For years Fluorouracil was the established treatment for pancreatic cancer with median survival times up to 8 months. Since 1997 Gemcitabine is also a standard therapy with in comparison to Fluorouracil a significant better clinical benefit.
But after progression of the disease under a palliative first-line therapy there is no established second line therapy for pancreatic cancer.
So the purpose of this study is to test the combination of Oxaliplatin and Docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy to get a reasonable second line concept.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Dated and signed informed concent
- Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV)
- Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy
- Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity
- Age >= 18 years
Key exclusion criteria (9 listed)
- Every other cancer or secondary cancer besides the basal cell carcinoma of the skin or the carcinoma in situ of the cervix uteri. Inclusion of patients with other types of cancer that were successfully treated and that did not relapse within the last 5 years is possible
- Pregnancy or lactation
- Patients able to reproduce that do not adhere to strict contraception
- Presence of brain metastasis
- Severe, uncontrolled infection
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 |
|---|---|---|
| DocetaxelAlso: Taxotere75 mg/m2 IV on day 1 of each 22 day cycle | Drug | – |
| OxaliplatinAlso: Eloxatin80 mg/m2 IV on day 2 of each 22 day cycle | Drug | – |
Primary outcome
tumor response
Time frame: 12/2009 and end of the study 12/2010
5 secondary outcomes
progression free survival
Time frame: 12/2009 and end of study 12/2010
overall survival
Time frame: 12/2009 and end of study 12/2010
Questionnaire for quality of life
Time frame: every three weeks
Questionnaire for clinical Benefit
Time frame: every week
toxicity / safety
Time frame: every week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2010.
- Derived from this study: PubMed 26772812Ettrich TJ, Perkhofer L, von Wichert G, Gress TM, Michl P, Hebart HF, Buchner-Steudel P, Geissler M, Muche R, Danner B, Kachele V, Berger AW, Guthle M, Seufferlein T. DocOx (AIO-PK0106): a phase II trial of docetaxel and oxaliplatin as a second line systemic therapy in patients with advanced pancreatic ductal adenocarcinoma. BMC Cancer. 2016 Jan 15;16:21. doi: 10.1186/s12885-016-2052-4.
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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.
Thomas Seufferlein, Prof. Dr. principal investigator
Universitätsklinikum Halle / Klinik für Innere Medizin I
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Oxaliplatin in people with Pancreas Neoplasms, run by University of Ulm at 5 sites in Germany.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Seufferlein, Prof. Dr. (49-345-5572661, thomas.seufferlein@medizin.uni-halle.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response (time frame: 12/2009 and end of the study 12/2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00690300, which also lists 1 linked publication.
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 3 Mar 2010.