Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

NCT00779454 | Completed Phase 2

• 3 other identifiers: GOX-PS-200800812612-3769
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cholangiocarcinoma

Keywords

KRAS wild-type; Cholangiocarcinoma; Inoperable

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Up to 6 months

Secondary Outcomes (2)

• Response rate

  6 months

• Overall survival

  6 months.

Study Arms (2)

KRAS wildtype

OTHER

Drug: Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine

KRAS mutation

OTHER

Inclusion has been completed in the KRAS mutation arm.

Drug: Gemcitabine, Oxaliplatin, Capecitabine,

Interventions

Gemcitabine, Oxaliplatin, Capecitabine, DRUG

Gemcitabin: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7

KRAS mutation

Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine DRUG

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

KRAS wildtype

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital, Dept. of Oncology

Vejle, DK-7100, Denmark

Location

Related Publications (2)

• Jensen LH, Andersen RF, Byriel L, Fernebro E, Jakobsen A, Lindebjerg J, Nottelmann L, Ploen J, Hansen TF. Phase II study of gemcitabine, oxaliplatin and capecitabine in patients with KRAS exon 2 mutated biliary tract cancers. Acta Oncol. 2020 Mar;59(3):298-301. doi: 10.1080/0284186X.2019.1701201. Epub 2019 Dec 14.

  PMID: 31838939 DERIVED

• Jensen LH, Lindebjerg J, Ploen J, Hansen TF, Jakobsen A. Phase II marker-driven trial of panitumumab and chemotherapy in KRAS wild-type biliary tract cancer. Ann Oncol. 2012 Sep;23(9):2341-2346. doi: 10.1093/annonc/mds008. Epub 2012 Feb 23.

  PMID: 22367707 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine; Oxaliplatin; Capecitabine; Panitumumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Anders Jakobsen, DMSc

  Vejle Hospital, Vejle, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 6, 2020

Record last verified: 2016-06

Locations

DK (1)