AdenocarcinomaPhase 2ATIPNCT00395252
Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer
A Phase 2 study testing Cetuximab (Erbitux®) and Gemcitabine in people with Adenocarcinoma, run by Carmen Schade-Brittinger at 8 sites in Germany.
Trial summary
This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Cetuximab (Erbitux®) and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 8 sitesGermany
- Study dates
- Oct 2006to Jan 2012
- 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
- Provided signed written informed consent.
- Men and woman age > 18 years
- Histologically confirmed R0 OR R1 resected ductal adenocarcinoma of the pancreas
- Life expectancy >12 weeks
- Patients with performance status of ECOG ≤ 2
- Patients without metastasis
Who cannot join
- Women of child bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and follow-up to 4 weeks after the study.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial).
- Inadequate hematologic function defined by an absolute neutrophils count (ANC) < 1,500/mm³, a platelet count < 100,000/mm³ and a hemoglobin < 9 g/dL.
Show all 15Show fewer
- Inadequate hepatic function defined by the upper limit of normal (ULN), AST and ALT levels > 5 times the ULN.
- Serum bilirubin > 1.5 times the ULN.
- Inadequate renal function defined by a serum creatinine > 1.5 times the ULN.
- Prior cetuximab or other therapy that targets the EGF pathway.
- Prior antibody therapy.
- Any known allergic reaction against cetuximab.
- Any concurrent chronic systemic immune therapy, radiation therapy, hormonal therapy (except for physiological replacement), or any other investigational agents.
- HIV infection.
- Having participated in another clinical trial in the preceding 30 days.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center)
Fulda, 36043
Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg
Heidelberg, 69120
Klinik für Innere Medizin II, Klinikum der Universität Jena
Jena, 07740
Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel
Kassel, 34125
Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH
Mannheim, 68167
Klinikum Giessen und Marburg, Standort Marburg
Marburg, 35033
II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München
Munich, 81675
Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg
Regensburg, 93042
About this study
Official title: Multicenter Phase II-trial to Investigate Safety and Efficacy of an Adjuvant Therapy With Gemcitabine and Erbitux® in Patients With R0 or R1 Resected Pancreatic Cancer
This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.
Read the detailed description
Available study data indicated a possible benefit from adjuvant chemotherapy for patients with resected pancreatic cancer. The optimal therapy regimen has yet to be determined.
Based on the experiences with cetuximab (Erbitux®)and gemcitabine in advanced pancreatic cancer and with gemcitabine as adjuvant therapy, the aim of this study was to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0 or R1-resectable pancreatic cancer and to evaluate if the disease free survival can be increased by the addition of an EGFR-targeted therapy.
- Conditions
- Adenocarcinoma
- Being tested
- Cetuximab (Erbitux®) and Gemcitabine
- Keywords
- pancreatic cancer, adjuvant chemotherapy, phase 2, R0 or R1 resected Adenocarcinoma of the Pancreas
- Medical subject headings
- Adenocarcinoma, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab (Erbitux®) and GemcitabineDrug
Also called Cetuximab, Gemzar
Cetuximab:
Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly for up to 6 months (treatment duration: 24 weeks)
Gemcitabine:
1000 mg/m2 administered on days 1, 8, 15 Cycles will be repeated on day 29, up to 6 treatment cycles will be administered
Mode of administration:
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| one arm study | Experimental | Cetuximab (Erbitux®) and Gemcitabine treatment over 6 months Receives: Drug: Cetuximab (Erbitux®) and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 18 months after registration
Secondary outcomes (3)
Overall survival
Quality of life
Incidence of Adverse Events
Measured: 19 months since registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionNov 2010
- Study completionJan 2012
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 AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmen Schade-Brittinger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmen Schade-Brittinger, Philipps University Marburg
- Investigators
- Thomas M Gress, Prof.Dr. med, Principal investigator, Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395252
- Sponsor's protocol ID
- EUDRACT-No. 2005-005168-94
- Acronym
- ATIP
- Status last verified
- Oct 2015
- First submitted
- 1 Nov 2006
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fensterer H, Schade-Brittinger C, Muller HH, Tebbe S, Fass J, Lindig U, Settmacher U, Schmidt WE, Marten A, Ebert MP, Kornmann M, Hofheinz R, Endlicher E, Brendel C, Barth PJ, Bartsch DK, Michl P, Gress TM; Arbeitsgemeinschaft Internistische Onkologie (AIO). Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP). Ann Oncol. 2013 Oct;24(10):2576-2581. doi: 10.1093/annonc/mdt270. Epub 2013 Jul 29.
PubMed 23897705
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II-trial to Investigate Safety and Efficacy of an Adjuvant Therapy With Gemcitabine and Erbitux® in Patients With R0 or R1 Resected Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00395252
- Acronym / sponsor ID
- ATIP / EUDRACT-No. 2005-005168-94
- Conditions
- Adenocarcinoma
- Keywords
- pancreatic cancer, adjuvant chemotherapy, phase 2, R0 or R1 resected Adenocarcinoma of the Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Carmen Schade-BrittingerUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Nov 2006 (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.
This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.
Detailed description
Available study data indicated a possible benefit from adjuvant chemotherapy for patients with resected pancreatic cancer. The optimal therapy regimen has yet to be determined.
Based on the experiences with cetuximab (Erbitux®)and gemcitabine in advanced pancreatic cancer and with gemcitabine as adjuvant therapy, the aim of this study was to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0 or R1-resectable pancreatic cancer and to evaluate if the disease free survival can be increased by the addition of an EGFR-targeted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm study | Experimental | Drug: Cetuximab (Erbitux®) and GemcitabineCetuximab (Erbitux®) and Gemcitabine treatment over 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provided signed written informed consent.
- Men and woman age > 18 years
- Histologically confirmed R0 OR R1 resected ductal adenocarcinoma of the pancreas
- Life expectancy >12 weeks
- Patients with performance status of ECOG ≤ 2
Key exclusion criteria (15 listed)
- Women of child bearing potential (WOCP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and follow-up to 4 weeks after the study.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial).
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 |
|---|---|---|
| Cetuximab (Erbitux®) and GemcitabineAlso: Cetuximab, GemzarCetuximab: Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly for up to 6 months (treatment duration: 24 weeks) Gemcitabine: 1000 mg/m2 administered on days 1, 8, 15 Cycles will be repeated on day 29, up to 6 treatment cycles will be administered Mode of administration: Intravenous infusion | Drug | one arm study |
Primary outcome
disease free survival
Time frame: 18 months after registration
3 secondary outcomes
Overall survival
Quality of life
Incidence of Adverse Events
Time frame: 19 months since registration
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 2 Oct 2015.
- Results publication: PubMed 23897705Fensterer H, Schade-Brittinger C, Muller HH, Tebbe S, Fass J, Lindig U, Settmacher U, Schmidt WE, Marten A, Ebert MP, Kornmann M, Hofheinz R, Endlicher E, Brendel C, Barth PJ, Bartsch DK, Michl P, Gress TM; Arbeitsgemeinschaft Internistische Onkologie (AIO). Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP). Ann Oncol. 2013 Oct;24(10):2576-2581. doi: 10.1093/annonc/mdt270. Epub 2013 Jul 29.
Related trials for Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
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 M Gress, Prof.Dr. med principal investigator
Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg
8 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 Cetuximab (Erbitux®) and Gemcitabine in people with Adenocarcinoma, run by Carmen Schade-Brittinger at 8 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 6 inclusion and 15 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 2 Oct 2015. 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 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?
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?
disease free survival (time frame: 18 months after registration). 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 NCT00395252, 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 2 Oct 2015.