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Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cholangiocarcinoma

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Trial Information

Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial.


Inclusion Criteria:

• Informed consent

- Age > 18 years

- Performance status 0-1; expected survival ≥ 3 months

- Patient with histologically or cytologically adenocarcinoma developed from cells in
the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent
with above mentioned and radiologic findings consistent with cholangiocarcinoma

- Liver metastases not suitable for surgery or other local treatment

- Extrahepatic disease should be excluded by PET-CT-scan.

- Prior treatment with chemotherapy or no progression on first line treatment

- Metastases < 70 % of the liver

- neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l

- bilirubin < 2.0 x UNL (upper normal limit).

- creatinine-clearance ≥ 30 ml/min.

- INR < 2.

- Intrahepatic treatment can be accomplished

- The patients is approved by a multidisciplinary team

Exclusion Criteria:• Other current or prior malignant disease except adequately treated
and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.

- Cytotoxic or experimental treatment within a 14 days period before start of trial
medication

- The patient is not allowed to participate in other clinical trials.

- Any clinical symptoms suggesting peripheral neuropathy grade 2

- Other severe medical conditions

- Severe cardial disease or AMI < 1 year

- Presence of diseases preventing oral therapy

- Patients with uncontrolled infection

- Pregnant or lactating women

- Women capable of childbearing not using a sufficient method of birth control

- Patients not able to understand the treatment or to collaborate

- Prior serious or unsuspected reaction after treatment with fluoropyrimidine

- Known prior hypersensitivity reactions to the agents

- Interstitial pneumonitis or pulmonary fibrosis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS

Outcome Description:

Time from treatment start to progression or death.

Outcome Time Frame:

6 months after last patient included

Safety Issue:

No

Principal Investigator

Magnus Bergenfeldt, Consultan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department og Gastroenterology

Authority:

Denmark: Danish Medicines Agency

Study ID:

GI 1003

NCT ID:

NCT01247337

Start Date:

November 2010

Completion Date:

March 2015

Related Keywords:

  • Cholangiocarcinoma
  • Neoplasm Metastasis
  • Cholangiocarcinoma

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