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CholangiocarcinomaPhase 2BTCNCT01267344

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

A Phase 2 study testing gemcitabine, oxaliplatin and cetuximab, gemcitabine, oxaliplatin in people with Cholangiocarcinoma and Adenocarcinoma of Gallbladder, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
gemcitabine, oxaliplatin and cetuximab, gemcitabine, oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteTaiwan
Study dates
Dec 2010to May 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Institute of Cancer Research, Taiwan Cooperative Oncology Group

    Zhunan, Miaoli County, 350

Other trials in Taiwan

About this study

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)

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.

Read the 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).

Being tested
gemcitabine, oxaliplatin, cetuximab, gemcitabine, oxaliplatin
Keywords
biliary tract cancer, BTC, cetuximaba
Medical subject headings
Cholangiocarcinoma, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabine, oxaliplatinDrug

    Also called Gemmis, Eloxatin

    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

  • cetuximab, gemcitabine, oxaliplatinDrug

    Also called Erbitux@, Eloxatin

    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.

Study groups in NCT01267344
Study groupRoleWhat they receive
GEMOXActive comparatorIntravenous 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.
Receives: Drug: gemcitabine, oxaliplatin
E-GEMOXExperimentalArm 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.
Receives: Drug: cetuximab, gemcitabine, oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline and every 8 weeks

Secondary outcomes (1)

  1. 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

    Measured: Baseline and every 2 weeks,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2013
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01267344
Sponsor's protocol ID
T1210
Acronym
BTC
Status last verified
Oct 2013
First submitted
14 Dec 2010
Last updated
4 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25632066

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine, oxaliplatin and cetuximab, gemcitabine, oxaliplatin in people with Cholangiocarcinoma and Adenocarcinoma of Gallbladder, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (time frame: baseline and every 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.

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BTC Clinical Trial NCT01267344 | AzTrials