Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is partly to continue the good experience the investigators have with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Capecitabine; Gemcitabine; Oxaliplatin; Panitumumab

Criteria

Inclusion Criteria:

• Histologically verified adenocarcinoma arisen from gallbladder, extra or intrahepatic bile ducts or malignant cells consistent with the above and concomitant radiologic findings consistent with cholangiocarcinoma.

• Curative treatment presently discounted (surgery, stereotactic radiotherapy, etc.)

• KRAS analyzed and found wild-type (wt) or mutated

• PS 0-2

• Evaluable disease according to RECIST criteria, i.e., the disease does not need to be measurable

• Haematology:

• ANC ≥ 1.5 x 10^9/l

• Thrombocytes ≥ 100x10^9/l

• Biochemistry:

• Bilirubinaemia ≤ 3 x upper normal value

• ALAT ≤ 5 x upper normal value

• Creatinin ≤ upper normal value. If raised creatinin, the measured or calculated GFR must be at least 50% of the lower normal value.

• Fertile women must present a negative pregnancy test and use birth control during and 3 months after treatment. The following methods are considered safe birth control: Birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid)

• Oral and written informed consent

Exclusion Criteria:

• Chemotherapy within 4 weeks

• Radiotherapy within 4 weeks

• Immunotherapy within 4 weeks

• Other concomitant experimental treatment

• Known neuropathy ≥ grade 2

• Serious congruous medical disease

• Other previous malignant disease within 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri

• Previous serious and unexpected reactions to fluoropyrimidine treatment

• Hypersensitivity to one or more of the active substances, auxiliary substances or fluoruracil

• Patients with interstitial pneumonitis or pulmonary fibrosis