Ampulla of Vater AdenocarcinomaPhase 1NCT01825603
ADH-1, Gemcitabine Hydrochloride & Cisplatin in Treating Metastatic Pancreatic or Biliary Tract Cancer
A Phase 1 study testing ADH-1, Cisplatin and Gemcitabine Hydrochloride in people with Ampulla of Vater Adenocarcinoma and Gallbladder Adenocarcinoma, run by University of Nebraska at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of ADH-1 when given together with gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread to other parts of the body… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ampulla of Vater Adenocarcinoma, Gallbladder Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- ADH-1, Cisplatin and Gemcitabine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2013to 1 Jun 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have adenocarcinoma of the pancreas or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder or ampulla of Vater) that is locally advanced, but non-resectable, metastatic or residual disease after attempted surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or better
- Absolute neutrophil count (ANC) of 2000 per mcL or higher
- Platelet count of 100,000 per mcL or higher
- Patients must have a serum creatinine that is at or below the upper limits of the institutional normal range OR a creatinine clearance of 60 mL per min or higher corrected for body surface area (BSA)
- The total bilirubin must be at or below 2.0 mg/dL in the absence of biliary obstruction; if the patient has biliary obstruction, biliary decompression will be required; either endoscopic placement of a biliary stent or percutaneous transhepatic drainage is acceptable; once biliary drainage has been established, institution of protocol therapy may proceed when the total bilirubin falls to 3.0 mg/dL or lower
Show all 10Show fewer
- Patients need not have measurable disease for this study
- The patient must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
- Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment
- Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study; (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Who cannot join
- Patients may not have received prior chemotherapy for metastatic adenocarcinoma of the pancreas or biliary tract; prior adjuvant chemotherapy is acceptable provided that 6 months or longer has elapsed since completion of the prior therapy
- History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
- Uncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that might jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety
- Pregnant and nursing women are excluded from this study
- Patients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Phase I Study of ADH-1 and Gemcitabine Plus Cisplatin in Patients With Unresectable or Metastatic Pancreatic and Biliary Tract Cancers
This phase I trial studies the side effects and best dose of ADH-1 when given together with gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread to other parts of the body (metastatic) and cannot be removed by surgery. ADH-1 may stop the growth of cancer cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ADH-1 together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the toxicities and determine the recommended dose of ADH-1 given twice weekly for 3 weeks in combination with cisplatin and fixed-dose rate gemcitabine (gemcitabine hydrochloride) given on weeks 1 and 2 of the 3 week schedule for 3 cycles in patients with locally advanced or metastatic pancreatic or biliary tract adenocarcinomas.
SECONDARY OBJECTIVES:
- To evaluate changes in the levels of intercellular adhesion molecule 1 (ICAM-1), E-selectin, vascular endothelial growth factor (VEGF), soluble vascular endothelial growth factor receptor (VEGFR) and basic fibroblast growth factor (B-FGF) during therapy with ADH-1, cisplatin and gemcitabine.
II. Radiographic assessment of disease status after 3 cycles of chemotherapy with ADH-1, cisplatin and gemcitabine.
III. To evaluate progression-free and overall survival of patients with locally advanced or metastatic pancreatic or biliary tract adenocarcinomas treated with ADH-1 given with cisplatin and fixed dose rate gemcitabine for 3 cycles. Patients with stable or responsive disease after 3 cycles will continue on maintenance cisplatin and fixed dose rate gemcitabine.
OUTLINE: This is a dose-escalation study of ADH-1.
Patients receive ADH-1 intravenously (IV) over 20-80 minutes on days 1, 4, 8, 11, 15, and 18, cisplatin IV and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease may receive maintenance therapy with cisplatin and gemcitabine hydrochloride.
After completion of study treatment, patients are followed up every 3 months for 2 years.
- Conditions
- Ampulla of Vater Adenocarcinoma, Gallbladder Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma, Stage III Ampulla of Vater Cancer, Stage III Intrahepatic Cholangiocarcinoma
- Being tested
- ADH-1, Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms, Gallbladder Neoplasms, Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADH-1Drug
Also called Exherin
Given IV
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ADH-1, cisplatin, gemcitabine hydrochloride) | Experimental | Patients receive ADH-1 IV over 20-80 minutes on days 1, 4, 8, 11, 15, and 18, cisplatin IV and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease may receive maintenance therapy with cisplatin and gemcitabine hydrochloride. Receives: Drug: ADH-1; Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose of ADH-1, defined as the highest dose tested which results in dose-limiting toxicities in no more than 1 of 6 evaluable patients based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.
Measured: 21 days
Secondary outcomes (3)
Changes in the levels of ICAM-1, E-selectin, VEGF, soluble VEGFR and B-FGF
Summarized using descriptive statistics
Measured: After all patients complete cycle 1, about 2 years after initial patient enrolled
Progression-free survival
Plotted following the method of Kaplan and Meier.
Measured: From the first date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 2 years
Survival
Plotted following the method of Kaplan and Meier.
Measured: From the first date of therapy until the date of death from any cause, assessed 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.
- First posted5 Apr 2013 (estimated)
- Study start9 Apr 2013
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ampulla of Vater AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Adherex Technologies, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jean L Grem, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825603
- Sponsor's protocol ID
- 0470-12-FB
- Other IDs
- NCI-2013-00406, P30CA036727, P50CA127297
- Status last verified
- Dec 2023
- First submitted
- 27 Mar 2013
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of ADH-1 and Gemcitabine Plus Cisplatin in Patients With Unresectable or Metastatic Pancreatic and Biliary Tract Cancers
- ClinicalTrials.gov ID
- NCT01825603
- Acronym / sponsor ID
- 0470-12-FB
- Conditions
- Ampulla of Vater Adenocarcinoma, Gallbladder Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma, Stage III Ampulla of Vater Cancer, Stage III Intrahepatic Cholangiocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Adherex Technologies, Inc., National Cancer Institute (NCI)
- Study start
- 9 Apr 2013 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 5 Apr 2013 (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.
This phase I trial studies the side effects and best dose of ADH-1 when given together with gemcitabine hydrochloride and cisplatin in treating patients with pancreatic or biliary tract cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread to other parts of the body (metastatic) and cannot be removed by surgery. ADH-1 may stop the growth of cancer cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ADH-1 together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the toxicities and determine the recommended dose of ADH-1 given twice weekly for 3 weeks in combination with cisplatin and fixed-dose rate gemcitabine (gemcitabine hydrochloride) given on weeks 1 and 2 of the 3 week schedule for 3 cycles in patients with locally advanced or metastatic pancreatic or biliary tract adenocarcinomas.
SECONDARY OBJECTIVES:
- To evaluate changes in the levels of intercellular adhesion molecule 1 (ICAM-1), E-selectin, vascular endothelial growth factor (VEGF), soluble vascular endothelial growth factor receptor (VEGFR) and basic fibroblast growth factor (B-FGF) during therapy with ADH-1, cisplatin and gemcitabine.
II. Radiographic assessment of disease status after 3 cycles of chemotherapy with ADH-1, cisplatin and gemcitabine.
III. To evaluate progression-free and overall survival of patients with locally advanced or metastatic pancreatic or biliary tract adenocarcinomas treated with ADH-1 given with cisplatin and fixed dose rate gemcitabine for 3 cycles. Patients with stable or responsive disease after 3 cycles will continue on maintenance cisplatin and fixed dose rate gemcitabine.
OUTLINE: This is a dose-escalation study of ADH-1.
Patients receive ADH-1 intravenously (IV) over 20-80 minutes on days 1, 4, 8, 11, 15, and 18, cisplatin IV and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease may receive maintenance therapy with cisplatin and gemcitabine hydrochloride.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ADH-1, cisplatin, gemcitabine hydrochloride) | Experimental | Drug: ADH-1, Drug: Cisplatin, Drug: Gemcitabine Hydrochloride, Other: Laboratory Biomarker AnalysisPatients receive ADH-1 IV over 20-80 minutes on days 1, 4, 8, 11, 15, and 18, cisplatin IV and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease may receive maintenance therapy with cisplatin and gemcitabine hydrochloride. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have adenocarcinoma of the pancreas or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder or ampulla of Vater) that is locally advanced, but non-resectable, metastatic or residual disease after attempted surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or better
- Absolute neutrophil count (ANC) of 2000 per mcL or higher
- Platelet count of 100,000 per mcL or higher
- Patients must have a serum creatinine that is at or below the upper limits of the institutional normal range OR a creatinine clearance of 60 mL per min or higher corrected for body surface area (BSA)
Key exclusion criteria (5 listed)
- Patients may not have received prior chemotherapy for metastatic adenocarcinoma of the pancreas or biliary tract; prior adjuvant chemotherapy is acceptable provided that 6 months or longer has elapsed since completion of the prior therapy
- History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
- Uncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that might jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety
- Pregnant and nursing women are excluded from this study
- Patients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 years
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 |
|---|---|---|
| ADH-1Also: ExherinGiven IV | Drug | Treatment (ADH-1, cisplatin, gemcitabine hydrochloride) |
| CisplatinAlso: Abiplatin, Blastolem, Briplatin, CDDPGiven IV | Drug | Treatment (ADH-1, cisplatin, gemcitabine hydrochloride) |
| Gemcitabine HydrochlorideAlso: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011Given IV | Drug | Treatment (ADH-1, cisplatin, gemcitabine hydrochloride) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (ADH-1, cisplatin, gemcitabine hydrochloride) |
Primary outcome
Recommended dose of ADH-1, defined as the highest dose tested which results in dose-limiting toxicities in no more than 1 of 6 evaluable patients based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: 21 days
The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.
3 secondary outcomes
Changes in the levels of ICAM-1, E-selectin, VEGF, soluble VEGFR and B-FGF
Time frame: After all patients complete cycle 1, about 2 years after initial patient enrolled
Progression-free survival
Time frame: From the first date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 2 years
Survival
Time frame: From the first date of therapy until the date of death from any cause, assessed up to 2 years
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 28 Dec 2023.
Related trials for Ampulla of Vater Adenocarcinoma
RecruitingObservational study
Hepatic Artery Infusion Pump Chemotherapy for Liver Metastases From Resected Pancreatic and Duodenal Adenocarcinoma
Pancreas Cancer With Hepatic Metastase, Pancreas Adenocarcinoma
RecruitingPhase 2
Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma
Locally Advanced Ampulla of Vater Carcinoma, Locally Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels
Foregut Adenocarcinoma, Esophageal Adenocarcinoma
Not yet recruitingPhase 2
Phase 2 Study of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer
Biliary Tract Cancers, Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruiting
WASH Trial: Intraoperative Lavage as a Treatment for Pancreatic Cancer
Acinar Cell Carcinoma, Ampulla of Vater 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.
Jean L Grem, MD principal investigator
University of Nebraska
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 ADH-1, Cisplatin and Gemcitabine Hydrochloride in people with Ampulla of Vater Adenocarcinoma and Gallbladder Adenocarcinoma, run by University of Nebraska 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 10 inclusion and 5 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 28 Dec 2023. 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?
Recommended dose of ADH-1, defined as the highest dose tested which results in dose-limiting toxicities in no more than 1 of 6 evaluable patients based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (time frame: 21 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 28 Dec 2023.