Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations

NCT01206049 | Completed Phase 2 DMC

• 1 other identifier: 2010-020385-13
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.

Conditions

Cholangiocarcinoma

Keywords

Cholangiocarcinoma; Inoperable; KRAS mutation; Biological treatment; Combination chemotherapy; Monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• The fraction of patients alive and without progression at 6 months

  6 months from enrollment date

Secondary Outcomes (3)

• Response rate before cross-over

  6 months after enrollment or earlier in case of progression

• Overall survival

  6 months

• Progression free survival and response rate after cross-over

  6 months

Study Arms (2)

Combination chemotherapy + panitumumab

EXPERIMENTAL

Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Panitumumab

Combination chemotherapy + bevacizumab

EXPERIMENTAL

Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab

Interventions

Gemcitabine DRUG

1,000 mg/m2 on day 1 of a 2 weeks cycle

Combination chemotherapy + bevacizumab; Combination chemotherapy + panitumumab

Oxaliplatin DRUG

60 mg/m2 on day 1 of a 2 weeks cycle

Combination chemotherapy + bevacizumab; Combination chemotherapy + panitumumab

Capecitabine DRUG

1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle

Combination chemotherapy + bevacizumab; Combination chemotherapy + panitumumab

Panitumumab DRUG

6 mg/kg on day 1 of a 2 weeks cycle

Combination chemotherapy + panitumumab

Bevacizumab DRUG

10 mg/kg on day 1 of a 2 weeks cycle

Combination chemotherapy + bevacizumab

Eligibility Criteria

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

You may qualify if:

• Histologically verified adenocarcinoma arisen from gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with the above and simultaneous radiologic findings consistent with cholangiocarcinoma
• Minimum 18 years of age
• Curative treatment currently not an option (operation, stereotactic radiation treatment or similar)
• KRAS analyzed and found wild-type (wt)
• Performance status 0-2
• Evaluable disease according to RECIST, i.e. the disease need not be measurable
• Hematology: ANC ≥1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l
• Biochemistry: Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal level.
• Creatinine ≤ upper normal level. At raised creatinine level the measured or calculated GFR must be at least 50% of the lower normal level
• Fertile women must present a negative pregnancy test and use secure birth control during and 6 months after treatment. Men with fertile partners must also take care of secure birth control.
• Written and orally informed consent

You may not qualify if:

• Previous cytostatic treatment of inoperable cholangiocarcinoma
• Adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start
• Other concomitant experimental treatment
• Severe medical disease such as considerable heart disease, serious active infection or other disease making the patient unfit for study participation as assessed by investigator
• Other malignant disease within 5 years prior to enrolment except from non-melanotic skin cancer and carcinoma in situ cervicis uteri
• Interstitial pneumonitis or subsequent pulmonary fibrosis
• Pregnant or breastfeeding women
• Large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment.
• Significant non-healing wound or ulcers
• Active hemorrhage or increased risk of hemorrhage (e.g. tumor invasion in large vessels or known esophagus varices)
• Known hypersensitivity to panitumumab, bevacizumab or any of the auxiliary agents
• Grade IV fistulas
• Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilized hypertension \>160/100
• Haemoptysis \> 2.5 ml within 2 weeks prior to enrolment
• Previous serious and unexpected reactions or know hypersensitivity to two or more of the applied cytostatics

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, DK-7100, Denmark

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine; Oxaliplatin; Capecitabine; Panitumumab; Bevacizumab

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, MD, DMSc

  Department of Oncology, Vejle Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 21, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 13, 2017

Record last verified: 2016-06

Locations

DK (1)