Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:

Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779454
• Other study ID #: GOX-P
• Secondary ID: S-200800812612-3
• Status: Completed
• Phase: Phase 2
• Start date: September 2008
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Cholangiocarcinoma is a relatively rare disease. In Denmark approximately 150 patients are diagnosed each year. A small part of the patients can be offered surgery, but the operation will rarely be radical, and most patients with cholangiocarcinoma are therefore candidates for chemotherapy.

In Denmark the combination therapy of Gemcitabine, Oxaliplatin and Capecitabine has been used in recent years. Based on experience with gastrointestinal tumors, however, there seems to be an effect of new biological substances, including EGFR antibodies. There are casuistic reports on the specific effect of a monoclonal antibody against EGFR in cholangiocarcinoma.

The effect of EGF is mediated through an intracellular pathway involving the KRAS protein. It has been shown that a mutation of KRAS causes the EGF system to be constantly activated. Effect in patients with a KRAS mutation is therefore not to be expected. Approximately 50% of the patients present this mutation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Drug:
• Gemcitabine, Oxaliplatin, Capecitabine,
Gemcitabin: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7
• Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
Gemcitabine: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7 Panitumumab: 6 mg/kg day 1

Locations

Country	Name	City	State
Denmark	Vejle Hospital, Dept. of Oncology	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		Up to 6 months
Secondary	Response rate		6 months
Secondary	Overall survival		6 months.