Extrahepatic Bile Duct CancerPhase 1NCT00987766
Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer
A Phase 1 study testing erlotinib hydrochloride, gemcitabine hydrochloride and oxaliplatin in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
- What is being tested?
- erlotinib hydrochloride, gemcitabine hydrochloride and oxaliplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2016
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only advanced carcinomas defined as unresectable or metastatic that are histologically or cytologically confirmed to be biliary tract, pancreas, duodenal, or ampullary carcinomas will be included.
- Dose-escalation: Patients > 18 years of age with biopsy-confirmed advanced biliary tract adenocarcinoma, pancreas cancer, duodenal cancer, or ampullary cancer
- MTD expansion cohort: Patients > 18 years of age with biopsy-confirmed advanced biliary tract adenocarcinoma only.
- No prior chemotherapy or prior EGF receptor inhibitor therapy
- Measurable tumor by imaging examination
- Performance status (PS) 0-2 on the ECOG performance scale
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- Have pretreatment bilirubin<2.5x upper limit of normal (ULN), serum creatinine<1.5x ULN, AST and ALT <2.5xULN or in the presence of liver metastasis <5xULN, neutrophils>1500, platelets>100K, hemoglobin >9 g/dL
- Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
- Have the ability to understand the requirements of the study and provide informed consent
Who cannot join
- CNS metastases
- Uncontrolled infection
- Pregnant or nursing women may not participate.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
- Psychiatric illness that would prevent understanding the nature of the investigational therapy and complying with protocol requirements
- Patients with > grade 2 neuropathy
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- Patients with > grade 2 uncontrolled nausea and vomiting despite antiemetics
- Any concurrent medical condition that, in the judgment of the investigator, would make the patient an inappropriate candidate for study enrollment
- Prior chemotherapy or EGFR inhibitor
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and oxaliplatin together with erlotinib hydrochloride may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with gemcitabine hydrochloride and oxaliplatin in treating patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose and the recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin in patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary cancer.
Secondary
- To describe any antitumor activity associated with this treatment regimen when given during the dose-escalation and expanded-cohort portions of this study.
- To evaluate e-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and assess their relationship to response.
OUTLINE: This is a multicenter, dose-escalation study of erlotinib hydrochloride.
Patients receive gemcitabine hydrochloride IV on day 1, oxaliplatin IV over 2 hours on day 2, and oral erlotinib hydrochloride once daily on days 3-8. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected for biomarker and other analysis.
After completion of study treatment, patients are followed up for 30 days.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer, Pancreatic Cancer, Periampullary Adenocarcinoma, Small Intestine Cancer
- Being tested
- erlotinib hydrochloride, gemcitabine hydrochloride, oxaliplatin, laboratory biomarker analysis
- Keywords
- advanced adult primary liver cancer, stage III pancreatic cancer, stage IV pancreatic cancer, periampullary adenocarcinoma, small intestine adenocarcinoma, adenocarcinoma of the extrahepatic bile duct, adenocarcinoma of the gallbladder, unresectable extrahepatic bile duct cancer, unresectable gallbladder cancer
- Medical subject headings
- Bile Duct Neoplasms, Gallbladder Neoplasms, Liver Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Taken daily by mouth for 6 days every other week.
Given through a vein in the arm 1 time every other week.
oxaliplatinDrug
Given through a vein in the arm 1 time every other week.
laboratory biomarker analysisOther
Blood and tissue collection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Gemcitabine + Oxaliplatin + Erlotinib Receives: Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride; Drug: oxaliplatin; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin
Measured: 28 days
Secondary outcomes (2)
Antitumor activity
Measured: 30 days after completing treatment.
E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response
Measured: 30 days after completing treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2013
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic Bile Duct CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Laura Goff, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987766
- Sponsor's protocol ID
- VICC GI 0906
- Other IDs
- P30CA068485
- Status last verified
- Jun 2017
- First submitted
- 30 Sep 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.
- ClinicalTrials.gov ID
- NCT00987766
- Acronym / sponsor ID
- VICC GI 0906
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer, Pancreatic Cancer, Periampullary Adenocarcinoma, Small Intestine Cancer
- Keywords
- advanced adult primary liver cancer, stage III pancreatic cancer, stage IV pancreatic cancer, periampullary adenocarcinoma, small intestine adenocarcinoma, adenocarcinoma of the extrahepatic bile duct, adenocarcinoma of the gallbladder, unresectable extrahepatic bile duct cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and oxaliplatin together with erlotinib hydrochloride may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with gemcitabine hydrochloride and oxaliplatin in treating patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose and the recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin in patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary cancer.
Secondary
- To describe any antitumor activity associated with this treatment regimen when given during the dose-escalation and expanded-cohort portions of this study.
- To evaluate e-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and assess their relationship to response.
OUTLINE: This is a multicenter, dose-escalation study of erlotinib hydrochloride.
Patients receive gemcitabine hydrochloride IV on day 1, oxaliplatin IV over 2 hours on day 2, and oral erlotinib hydrochloride once daily on days 3-8. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected for biomarker and other analysis.
After completion of study treatment, patients are followed up for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: erlotinib hydrochloride, Drug: gemcitabine hydrochloride, Drug: oxaliplatin, Other: laboratory biomarker analysisGemcitabine + Oxaliplatin + Erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Only advanced carcinomas defined as unresectable or metastatic that are histologically or cytologically confirmed to be biliary tract, pancreas, duodenal, or ampullary carcinomas will be included.
- Dose-escalation: Patients > 18 years of age with biopsy-confirmed advanced biliary tract adenocarcinoma, pancreas cancer, duodenal cancer, or ampullary cancer
- MTD expansion cohort: Patients > 18 years of age with biopsy-confirmed advanced biliary tract adenocarcinoma only.
- No prior chemotherapy or prior EGF receptor inhibitor therapy
- Measurable tumor by imaging examination
Key exclusion criteria (9 listed)
- CNS metastases
- Uncontrolled infection
- Pregnant or nursing women may not participate.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
- Psychiatric illness that would prevent understanding the nature of the investigational therapy and complying with protocol requirements
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 |
|---|---|---|
| erlotinib hydrochlorideTaken daily by mouth for 6 days every other week. | Drug | Treatment |
| gemcitabine hydrochlorideGiven through a vein in the arm 1 time every other week. | Drug | Treatment |
| oxaliplatinGiven through a vein in the arm 1 time every other week. | Drug | Treatment |
| laboratory biomarker analysisBlood and tissue collection. | Other | Treatment |
Primary outcome
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin
Time frame: 28 days
2 secondary outcomes
Antitumor activity
Time frame: 30 days after completing treatment.
E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response
Time frame: 30 days after completing treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
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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.
Laura Goff, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing erlotinib hydrochloride, gemcitabine hydrochloride and oxaliplatin in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
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 9 inclusion and 9 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 2 Jul 2017. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.