Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Unresectable pancreatic cancer
Intervention
EMD 121974 and gemcitabine versus gemcitabine alone
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Gemcitabine, EMD 121974
Primary outcome measure
Overall survival
Secondary outcome measures
1. Response
2. Progression
3. Safety
4. Quality of Life
5. Biomarkers
Overall study start date
15/10/1999
Overall study end date
07/08/2001
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
60
Participant exclusion criteria
1. In the investigators 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 patients 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 patients 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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/12/2006 | Yes | No |