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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Metastases, Colorectal Cancer

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Trial Information

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


Inclusion Criteria:



- Histopathologically confirmed complete resection (R0) of liver metastases from
colorectal adenocarcinoma

- Age ≥18 years

- ECOG performance status ≤ 2

- Patient was informed, has read and understood the patient information / informed
consent form and has given written informed consent

Exclusion Criteria:

- Extra-hepatic distant metastases or locally recurrent disease at time of enrolment

- Neoadjuvant chemotherapy of liver metastases prior to surgery

- Any anticancer chemotherapy within 4 weeks prior to study entry

- Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry

- Any biological anticancer therapy or immunotherapy within 4 weeks prior to study
entry

- Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery

- Treatment with any investigational product within a time range of 4-5 half-lives (t½)
prior to study entry

- Acute or chronic pancreatitis or history of alcohol induced pancreatitis

- Liver cirrhosis, acute hepatitis or chronic hepatic disease

- Any unresolved complications from prior surgery

- Persistent neuropathy

- 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)

- History of inflammatory bowel disease

- Active severe infection, any other concurrent disease or medical condition that is
deemed to interfere with the conduct of the study as judged by the investigator

- Use of immune-suppressive agents such as the regular use of systemic corticosteroids

- HIV positivity

- 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

- Pregnant or nursing women

- 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

- Not willing or incapable to comply with all study visits and assessments

- Placed into an institution due to juridical or regulatory ruling

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival rate (DFS)

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Peter Neuhaus, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Virchow Klinikum, Berlin

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

MT201-204

NCT ID:

NCT00866944

Start Date:

March 2009

Completion Date:

November 2011

Related Keywords:

  • Liver Metastases
  • Colorectal Cancer
  • Colorectal carcinoma
  • Liver metastases (only)
  • R0 resection
  • R0 resection of liver metastases from colorectal cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location