A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Health Research Institutes, Taiwan
Sponsor:
Collaborators:
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Tri-Service General Hospital
Chang Gung Memorial Hospital
Taichung Veterans General Hospital
China Medical University Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01267344
First received: December 14, 2010
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Adenocarcinoma of Gallbladder
Drug: gemcitabine, oxaliplatin
Drug: cetuximab, gemcitabine, oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Gemcitabine Plus Oxaliplatin (GEMOX) With or Without Cetuximab in Locally Advanced and Metastatic Biliary Tract Cancer (BTC)

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • objective response rate [ Time Frame: baseline and every 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • The toxicity profiles of the combination treatments [ Time Frame: Baseline and every 2 weeks, ] [ Designated as safety issue: Yes ]
    Treatment toxicity will be graded by NCI Common Toxicity Criteria Version 4.0 (CTC, v4.0) for safety evaluation


Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: gemcitabine, oxaliplatin
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
Other Name: Gemmis, Eloxatin
Experimental: E-GEMOX
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
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.
Other Name: Erbitux@, Eloxatin

Detailed Description:

It is considered realistic, that within 18 months 120 patients can be included in the participating centers. Based on the previous publications an objective response rate (ORR) of 20% is expected in the GEMOX arm (Arm B). When the sample size of evaluable patients is between 110 and 120 evaluable patients (ie. 55 to 60 patients per treatment arm), then a two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB, of 20% and an arm A response rate PA of 30%, 35% or 40% based on the large sample normal approximation will have a width between 15.4% and 16.7%. We assume an objective response rate of 30% for Arm A, then a two-sided 95% confidence interval (CI) for the difference between an arm B response rate PB, of 20% and an arm A response rate PA of 30% will have a width ±15.4% when the sample size of evaluable patients is 120 (i.e., 60 patients per treatment arm).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267344

Contacts
Contact: Chang Su Tsai, MD +886-6-7000123 ext 65131 chonsone@gmail.com
Contact: Yung Hs Chin, RN +886-37-246166 ext 35119 yhchin@nhri.org.tw

Locations
Taiwan
National Institute of Cancer Research, Taiwan Cooperative Oncology Group Recruiting
Zhunan, Miaoli County, Taiwan, 350
Contact: Chang Su Tsai, MD    +886-6-7000123 ext 65131    chonsone@gmail.com   
Principal Investigator: Yee Chao, PHD         
Principal Investigator: Jen Sh Chen, MD         
Principal Investigator: Ruey Ku Hsieh, PHD         
Principal Investigator: Chin Hsu, PHD         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Tri-Service General Hospital
Chang Gung Memorial Hospital
Taichung Veterans General Hospital
China Medical University Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University
Kaohsiung Veterans General Hospital.
Investigators
Study Chair: Li Tz Chen, PHD National Institute of Cancer Research
Study Director: Tsang Wu Liu, MD National Institute of Cancer Research, TCOG
  More Information

No publications provided

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01267344     History of Changes
Other Study ID Numbers: T1210
Study First Received: December 14, 2010
Last Updated: October 28, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Health Research Institutes, Taiwan:
biliary tract cancer
BTC
cetuximaba

Additional relevant MeSH terms:
Adenocarcinoma
Cholangiocarcinoma
Biliary Tract Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014