Condition category
Cancer
Date applied
23/01/2006
Date assigned
17/03/2006
Last edited
21/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Helmut Friess

ORCID ID

Contact details

Abteilung fur Allgemeine
Viszerale-und Unfallchirurgie
Universitat Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMD 121974-004

Study information

Scientific title

Acronym

Study hypothesis

Primary:
1. To investigate the effects of treatment with EMD 121974 and gemcitabine compared to gemcitabine alone on the overall survival in patients with advanced, unresectable pancreatic cancer

Secondary:
1. To investigate the response rates including stable disease
2. To determine the best of all response rates
3. To determine the time to disease progression
4. To assess the safety and tolerability
5. To assess the quality of life
6. To determine the performance status
7. To investigate the biological response (tumor marker levels, and angiogenic growth factor levels)
8. To evaluate the population pharmacokinetic parameters for EMD 121974 as well as gemcitabine and to determine plasma concentration-effect relationships for EMD 121974 with adverse events, primary efficacy parameters, and demographic data

Ethics approval

Approved by the Institutional boards of the participating centers

Study design

Open label, controlled, randomized

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Unresectable pancreatic cancer

Intervention

EMD 121974 and gemcitabine versus gemcitabine alone

Intervention type

Drug

Phase

Not Specified

Drug names

Gemcitabine, EMD 121974

Primary outcome measures

Overall survival

Secondary outcome measures

1. Response
2. Progression
3. Safety
4. Quality of Life
5. Biomarkers

Overall trial start date

15/10/1999

Overall trial end date

07/08/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. The patient must have provided written informed consent prior to any study-related procedure
2. The patient must be at least 18 years of age
3. The patient must be male or female without childbearing potential (i.e. post-menopausal or sterile)
4. The patient must suffer from histologically confirmed advanced unresectable pancreatic cancer with or without metastases
5. The patient must have at least one bidimensionally measurable or evaluable lesion
6. The life expectancy of the patient must be at least 12 weeks
7. The patient must have a Karnofsky performance score of = 70%
8. Outpatients as well as inpatients can be selected for this study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. In the investigator’s opinion, if the patient is not able to comply with the protocol regulations
2. The patient is a pregnant or lactating female. Females with childbearing potential are generally excluded from the study.
3. The patient has received chemotherapy, and/or major surgery related to the pancreatic cancer prior to study entry. Palliative surgeries (e.g. for the placement of stents) or explorative laparotomies do not fall into this category.
4. The patient has received prior antiangiogenic therapy
5. The patient’s laboratory parameters lie within the following ranges: pre-treatment granulocytes <1500 /ml, haemoglobin <9 g/dl, platelet count <100,000 /ml, pre-treatment bilirubin >3 times the upper limit of normal, pre-treatment creatinine >2 times the upper limit of normal
6. The patient’s liver transaminases lie within the following ranges: serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) >5 times the upper limit of normal
7. The patient has had a second primary malignancy within the past five years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin
8. The patient has a history of brain metastases. In case of suspected brain metastases, a computer tomography (CT) scan of the skull will be performed. This is not mandatory in asymptomatic patients.
9. The patient has had a major surgery within four weeks of study entry
10. The patient has a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
11. The patient has had bypass surgery within six months of study entry, or has clinically significant cardiac or cardiovascular abnormalities (New York Heart Association [NYHA] III/IV) or unstable angina or arrhythmias (Lown class IV) requiring treatment
12. The patient has abnormal clotting disorders as defined by international normalized ratio (INR) >1.5, prothrombin time >18 seconds or activated partial thromboplastin time (APTT) >60 seconds, or patients on anticoagulant therapies. Migratory thrombophlebitis does not fall into this category.
13. The patient is suffering from severe diabetic angiopathy due to a long history of diabetes mellitus
14. The patient has had gastric or duodenal ulcers within six months of study entry, or is at risk of gastrointestinal ulceration due to a high consumption of non-steroidal anti-inflammatory drugs (NSAIDs)
15. The patient has a known active infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
16. The patient is suffering from serious uncontrolled infections
17. The patient has a history of allergies against penicillin
18. The patient has a legal incapacity or a limited legal capacity
19. The patient is known for drug abuse or extensive chronic use of alcohol
20. The patient takes or is likely to need prohibited concomitant medication
21. The patient has participated in another clinical study within 30 days of study entry
22. Fertile men not willing to use contraception

Recruitment start date

15/10/1999

Recruitment end date

07/08/2001

Locations

Countries of recruitment

Germany

Trial participating centre

Abteilung fur Allgemeine
Heidelberg
69120
Germany

Sponsor information

Organisation

Merck KGaA (Germany)

Sponsor details

Frankfurter Strasse 250
Darmstadt
64293
Germany

Sponsor type

Industry

Website

http://www.merck.de

Funders

Funder type

Industry

Funder name

Merck KGaA (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17156477

Publication citations

  1. Results

    Friess H, Langrehr JM, Oettle H, Raedle J, Niedergethmann M, Dittrich C, Hossfeld DK, Stöger H, Neyns B, Herzog P, Piedbois P, Dobrowolski F, Scheithauer W, Hawkins R, Katz F, Balcke P, Vermorken J, van Belle S, Davidson N, Esteve AA, Castellano D, Kleeff J, Tempia-Caliera AA, Kovar A, Nippgen J, A randomized multi-center phase II trial of the angiogenesis inhibitor Cilengitide (EMD 121974) and gemcitabine compared with gemcitabine alone in advanced unresectable pancreatic cancer., BMC Cancer, 2006, 6, 285, doi: 10.1186/1471-2407-6-285.

Additional files

Editorial Notes