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

Primary Purpose

Cholangiocarcinoma, Adenocarcinoma of Gallbladder

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

gemcitabine, oxaliplatin

cetuximab, gemcitabine, oxaliplatin

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring biliary tract cancer, BTC, cetuximaba

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institute of Cancer Research, Taiwan Cooperative Oncology Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GEMOX

E-GEMOX

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The toxicity profiles of the combination treatments

Treatment toxicity will be graded by NCI Common Toxicity Criteria Version 4.0 (CTC, v4.0) for safety evaluation

Full Information

NCT ID

NCT01267344

First Posted

December 14, 2010

Last Updated

May 3, 2016

Sponsor

National Health Research Institutes, Taiwan

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.

1. Study Identification

Unique Protocol Identification Number

NCT01267344

Brief Title

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

Acronym

BTC

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Health Research Institutes, Taiwan

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma, Adenocarcinoma of Gallbladder

Keywords

biliary tract cancer, BTC, cetuximaba

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GEMOX

Arm Type

Active Comparator

Arm Description

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.

Arm Title

E-GEMOX

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

gemcitabine, oxaliplatin

Other Intervention Name(s)

Gemmis, Eloxatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cetuximab, gemcitabine, oxaliplatin

Other Intervention Name(s)

Erbitux@, Eloxatin

Intervention Description

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.

Primary Outcome Measure Information:

Title

objective response rate

Description

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.

Time Frame

baseline and every 8 weeks

Secondary Outcome Measure Information:

Title

The toxicity profiles of the combination treatments

Description

Treatment toxicity will be graded by NCI Common Toxicity Criteria Version 4.0 (CTC, v4.0) for safety evaluation

Time Frame

Baseline and every 2 weeks,

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Tz Chen, PHD

Organizational Affiliation

National Institute of Cancer Research

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tsang Wu Liu, MD

Organizational Affiliation

National Institute of Cancer Research, TCOG

Official's Role

Study Director

Facility Information:

Facility Name

National Institute of Cancer Research, Taiwan Cooperative Oncology Group

City

Zhunan

State/Province

Miaoli County

ZIP/Postal Code

350

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

25632066

Citation

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.

Results Reference

derived

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

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