NCT01267344

Brief Summary

The primary objective is to investigate the objective response rate in patients receiving GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer compared to patients receiving the same chemotherapy without cetuximab. The secondary objectives include the exploration of the effect of the multimodality strategy on progression-free and overall survival, biomarker prediction, and toxicity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 4, 2016

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

December 14, 2010

Last Update Submit

May 3, 2016

Conditions

CholangiocarcinomaAdenocarcinoma of Gallbladder

Keywords

biliary tract cancerBTCcetuximaba

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    Evaluation of tumor response according to RECIST 1.1 version Evaluation will be done at baseline and every 8 weeks. Evaluation will be performed with CT or MRI.

    baseline and every 8 weeks

Secondary Outcomes (1)

  • The toxicity profiles of the combination treatments

    Baseline and every 2 weeks,

Study Arms (2)

GEMOX

ACTIVE COMPARATOR

Intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks.

Drug: gemcitabine, oxaliplatin

E-GEMOX

EXPERIMENTAL

Arm A will receive E-GEMOX with additional intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above.

Drug: cetuximab, gemcitabine, oxaliplatin

Interventions

gemcitabine, oxaliplatinDRUG

GEMOX (intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks

Also known as: Gemmis, Eloxatin
GEMOX
cetuximab, gemcitabine, oxaliplatinDRUG

E-GEMOX: intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above. All of the study medication will be administrated on day 1 every 2 weeks, which is regarded as one cycle.

Also known as: Erbitux@, Eloxatin
E-GEMOX

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cyto-/histological confirmed unresectable, locally advanced, or metastatic biliary tract cancer, including intrahepatic or extrahepatic cholangiocarcinoma or adenocarcinoma of gallbladder, but NOT other peri-ampulla Vateri or mixed tumor.
  • At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
  • Aged no less than 20 years, at the time of acquisition of informed consent.
  • Life expectancy \>= 3 months.
  • Adequate organ and bone marrow function as defined below: WBC \>= 3.00 × 103/L and absolute neutrophil count \>= 1.50 × 103/L, Platelet count \>= 100 × 103/L, Hemoglobin level \>= 10 g/dL, Serum creatinine \<= 1.5 x Upper Normal Limit (UNL) and calculated GFR \>= 40mL/min, Serum bilirubin \<= 1.5 x UNL , ALT \<= 2.5x UNL.
  • Ability to understand and willingness to sign written Informed Consent Form.

You may not qualify if:

  • Other anti-tumor agent such as systemic chemotherapy, immunotherapy or EGFR/VEGF-pathway-targeting therapy before the commencement of study treatment.
  • Radiotherapy (except palliative irradiation of bone lesions) within 4 weeks before the commencement of study treatment.
  • Other cancer or prior treatment for other carcinomas within the last five years, except cured non-melanoma skin cancer and treated in-situ cervical cancer.
  • Known CNS metastasis.
  • Major surgery within 4 weeks prior to start of study treatment (diagnostic biopsy, laparotomy, line placement is not considered as major surgery).
  • Pre-existing peripheral neuropathy \>= grade 2.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction in the past 12 months, active gastrointestinal bleeding, central nervous system disorders or psychiatric illness/social situation that would limit compliance with study requirements or judged to be ineligible for the study by the investigator.
  • Having received any investigational agents or participated in any investigational drug study within 4 weeks prior to study enrollment.
  • Pregnant or breast-feeding female (a pregnancy test must be performed on all female patients who are of child-bearing potential before entering the study, and the result must be negative).
  • Poor compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cancer Research, Taiwan Cooperative Oncology Group

Zhunan, Miaoli County, 350, Taiwan

Location

Related Publications (1)

  • Chen JS, Hsu C, Chiang NJ, Tsai CS, Tsou HH, Huang SF, Bai LY, Chang IC, Shiah HS, Ho CL, Yen CJ, Lee KD, Chiu CF, Rau KM, Yu MS, Yang Y, Hsieh RK, Chang JY, Shan YS, Chao Y, Chen LT; Taiwan Cooperative Oncology Group. A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer. Ann Oncol. 2015 May;26(5):943-949. doi: 10.1093/annonc/mdv035. Epub 2015 Jan 28.

    PMID: 25632066DERIVED

MeSH Terms

Conditions

CholangiocarcinomaBiliary Tract Neoplasms

Interventions

gemcitabine-oxaliplatin regimenOxaliplatinCetuximabGemcitabine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Li Tz Chen, PHD

    National Institute of Cancer Research

    STUDY CHAIR

  • Tsang Wu Liu, MD

    National Institute of Cancer Research, TCOG

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 28, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

May 1, 2015

Last Updated

May 4, 2016

Record last verified: 2013-10

Locations

TW(1)