A randomized, open-label, controlled, multi-center Phase II study to evaluate the efficacy and safety of adecatumumab alone or sequentially to FOLFOX relative to FOLFOX after R0 resection of colorectal liver metastases

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2008-004706-14-FR
• Date of registration: 24/03/2009
• Prospective Registration: Yes
• Primary sponsor: Micromet AG
• Public title: A randomized, open-label, controlled, multi-center Phase II study to evaluate the efficacy and safety of adecatumumab alone or sequentially to FOLFOX relative to FOLFOX after R0 resection of colorectal liver metastases
• Scientific title: A randomized, open-label, controlled, multi-center Phase II study to evaluate the efficacy and safety of adecatumumab alone or sequentially to FOLFOX relative to FOLFOX after R0 resection of colorectal liver metastases
• Date of first enrolment: 30/04/2009
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004706-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histopathologically confirmed complete resection (R0) of liver metastasis(es) from colorectal adenocarcinoma (additional confirmation by CT scan at treatment start)
2. Age =18 years
3. ECOG performance status = 2
4. Ability to understand and willingness to sign a written informed consent.

The following eligibility criteria must be fulfilled before the patient can be treated with study medication:

1. CT confirmation of complete resection (R0) of liver metastasis(es) (and histopathological confirmation of tumor-free margin)
2. Organ or bone marrow function at time of treatment start as defined below:
a. WBC > 3 Gpt/l (3x109/L, 3000/mm3)
b. Platelet count > 100 Gpt/l (100x109/L, 100,000/mm³)
c. Creatinine clearance = 50 ml/min (calculated e.g. according to MDRD)
d. Serum bilirubin < 2 x upper limit of normal (ULN)
e. AST (SGOT)/ALT (SGPT) = 5 x upper limit of normal (ULN)
f. Serum lipase < upper limit of normal (ULN)
g. Neutrophils > 2 Gpt/l (2x109/l, 2000/mm³)
3. Blood coagulation at time of treatment start as defined below:
a. INR < 1.5 x upper limit of normal
b. PTT < 1.5 x upper limit of normal(sec)
4. Investigator’s discretion that the clinical condition of the patient allows start of treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
2. Neoadjuvant chemotherapy for liver metastases prior to surgery
3. Any anticancer chemotherapy within 4 weeks prior to study entry
4. Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
5. Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry
6. Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery
7. Treatment with any investigational product within a time range of 4-5 half-lives (t½) prior to study entry
8. Acute or chronic pancreatitis or history of alcohol induced pancreatitis
9. Liver cirrhosis, acute hepatitis or chronic hepatic disease
10. Any unresolved complications from surgery
11. Persistent neuropathy
12. History of other malignancy within 5 years prior to study start, with the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix and Ductal Carcinoma in Situ (DCIS)
13. History of inflammatory bowel disease
14. Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
15. Use of immune-suppressive agents such as the regular use of systemic corticosteroids
16. HIV positivity
17. Known hypersensitivity or intolerability to immunoglobulins in general, other recombinant human or humanized antibodies, Folinic Acid, 5-Fluorouracil, Oxaliplatin or a component of the study drug formulations, known dihydropyrimidine dehydrogenase (DPD) deficiency
18. Pregnant or nursing women
19. Women of childbearing potential or male patients not willing to use an effective form of contraception during treatment phase of the study and at least 6 months thereafter
20. Not willing or incapable to comply with all study visits and assessments
21. Placed into an institution due to juridical or regulatory ruling
22. Vaccination with live vaccines (e.g. yellow fever)
23. Concomitant treatment with phenytoin


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

R0 resected liver metastases from colorectal cancer

Intervention(s)

Product Name: adecatumumab
Product Code: MT201
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: adecatumumab
CAS Number: 503605-661
Current Sponsor code: MT201
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Eloxatin
Product Name: oxaliplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: oxaliplatin
CAS Number: 63121-00-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentration number: 5-

Product Name: calcium folinate
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: calcium folinate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Name: 5 Fluorouracil
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: 5 fluorouracil
CAS Number: 51-21-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: To assess the effect of the monoclonal AB adecatumumab alone or sequentially to FOLFOX on 1 year disease-free survival (DFS) rates in colorectal cancer patients with complete (R0) resection of liver metastases

Primary end point(s): One year disease free survival (DFS) rate, defined by the ratio of disease-free patients one year after randomization to total patients per treatment arm

Secondary Objective: •To assess the 1 year disease-free survival (DFS) rate after treatment with FOLFOX.
•To compare 1 year disease-free survival (DFS) rate of the treatment with the monoclonal AB adecatumumab alone or sequentially to FOLFOX to treatment with FOLFOX.
•To assess the disease free survival (DFS) of patients in the three treatment arms at 2 and 3 years after randomization.
•To assess the time-to-relapse (TTR) and relapse rates for patients in the three treatment arms.
•To assess the safety profile in the three treatment arms.
•To assess the quality of life for the three treatment arms.

Secondary ID(s)

2008-004706-14-DE

MT201-204

Ethics review

Status: Approved
Approval date: 10/04/2009
Contact:

Results

• Results available: Yes
• Date Posted: 03/11/2016
• Date Completed: 29/07/2011
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-004706-14/results