Biliary Tract CancerPhase 2NCT00380588

Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer

A Phase 2 study testing gemcitabine and cisplatin in people with Biliary Tract Cancer, run by Eli Lilly and Company at 7 sites in Japan.

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

To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Biliary Tract Cancer
What is being tested?: gemcitabine and cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 7 sitesJapan
Study dates: Sep 2006to Oct 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histological or cytological diagnosis of biliary tract cancer
Measurable disease must be at least one lesion
Chemotherapy-naïve
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Estimated life expectancy no less than 3 months

Who cannot join

radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, 466-8560
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, 277-8577
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, 811-1395
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hokkaido, 060-8648
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kanagawa, 241-0815
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shizuoka, 411-8777
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, 104-0045

Other trials in Japan

About this study

Official title: A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer

To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer

Conditions: Biliary Tract Cancer
Being tested: gemcitabine, cisplatin
Medical subject headings: Biliary Tract Neoplasms

What participants receive

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

gemcitabineDrug
Also called LY188011, Gemzar
1000 milligrams per square meter (mg/m2), intravenous (IV)
cisplatinDrug
25 milligrams per square meter (mg/m2), intravenous (IV)

Study groups in NCT00380588
Study group	Role	What they receive
Gemcitabine + Cisplatin	Experimental	Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Receives: Drug: gemcitabine; Drug: cisplatin
Gemcitabine	Experimental	Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Receives: Drug: gemcitabine

What is being measured

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

Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
Percentage of patients alive at 1 year.
Measured: 1 year

Secondary outcomes (2)

Tumor Response
Response Evaluation Criteria In Solid Tumors - define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria.
Measured: baseline to measured progressive disease (up to 2 years)
Progression Free Survival
The period from study entry until disease progression, death or date of last contact.
Measured: baseline to measured progressive disease (up to 2 years)

Timeline

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

Sep 2006Oct 2008

First posted26 Sep 2006 (estimated)
Study startSep 2006
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00380588
Sponsor's protocol ID: 10298
Other IDs: B9E-JE-BT22
Status last verified: Nov 2009
First submitted: 22 Sep 2006
Last updated: 20 Nov 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Enrolling by invitationPhase 2
Vedotin for Injection in Second-line or Later Treatment of Advanced Biliary Tract Cancer
Biliary Tract Neoplasms
RecruitingPhase 2
Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT for BTC With Lymph Node Metastases
Biliary Tract Cancer (BTC), Surgery
RecruitingPhase 1/2
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma

All Biliary Tract Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer
ClinicalTrials.gov ID: NCT00380588
Acronym / sponsor ID: 10298
Conditions: Biliary Tract Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 26 Sep 2006 (estimated)
Results: Posted 19 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gemcitabine + Cisplatin	Experimental	Drug: gemcitabine, Drug: cisplatinGemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Gemcitabine	Experimental	Drug: gemcitabineGemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Histological or cytological diagnosis of biliary tract cancer
Measurable disease must be at least one lesion
Chemotherapy-naïve
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Estimated life expectancy no less than 3 months

Key exclusion criteria (1 listed)

radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
gemcitabineAlso: LY188011, Gemzar1000 milligrams per square meter (mg/m2), intravenous (IV)	Drug	Gemcitabine, Gemcitabine + Cisplatin
cisplatin25 milligrams per square meter (mg/m2), intravenous (IV)	Drug	Gemcitabine + Cisplatin

Primary outcome

Percentage of Patients Alive at 1 Year (1-Year Survival Rate)
Time frame: 1 year
Percentage of patients alive at 1 year.

2 secondary outcomes

Tumor Response
Time frame: baseline to measured progressive disease (up to 2 years)
Progression Free Survival
Time frame: baseline to measured progressive disease (up to 2 years)

Results and safety

Results posted to the registry on 19 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gemcitabine + Cisplatin	42	3
Gemcitabine	42	2

Primary outcome: Percentage of Patients Alive at 1 Year (1-Year Survival Rate)

Time frame: 1 year. Number. Unit: percentage of participants

Measure	Gemcitabine + Cisplatin n = 41	Gemcitabine n = 42
Value	39	31

Population analysed: Number of patients who received at least one dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine + Cisplatin	9 of 41 (22%)	41 of 41 (100%)	Not reported
Gemcitabine	17 of 42 (40.5%)	42 of 42 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Biliary Tract Cancer

RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Enrolling by invitationPhase 2
Vedotin for Injection in Second-line or Later Treatment of Advanced Biliary Tract Cancer
Biliary Tract Neoplasms
RecruitingPhase 2
Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT for BTC With Lymph Node Metastases
Biliary Tract Cancer (BTC), Surgery
RecruitingPhase 1/2
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine and cisplatin in people with Biliary Tract Cancer, run by Eli Lilly and Company at 7 sites in Japan.

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 5 inclusion and 1 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 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 19 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Alive at 1 Year (1-Year Survival Rate) (time frame: 1 year). 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 NCT00380588.

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 20 Nov 2009; AzTrials last refreshed its copy on 26 Oct 2026.