Pancreatic CancerPhase 1NCT00626158
Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers
A Phase 1 study testing gemcitabine and capecitabine in people with Pancreatic Cancer and Biliary Cancer, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The purpose of this study is to find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Biliary Cancer
- What is being tested?
- gemcitabine and capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Dec 2010
- 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
- Histologically-confirmed pancreatic adenocarcinoma or biliary tract carcinoma (cholangiocarcinoma or gallbladder cancer)
- Disease must not be amenable to surgical resection. Patients with either locally advanced or metastatic disease are eligible
- No prior systemic therapy for their diagnosis
- ECOG performance score of 0-1
- Evidence of either or both of the following:
- RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)
Show all 22Show fewer
- An elevated serum CA19-9 at baseline ( ≥ 2X ULN)
- Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.
- Adequate bone marrow function:
- ANC ≥ 1500/uL
- platelet count ≥ 100,000/uL
- hemoglobin ≥ 9.0 g/dL
- Adequate hepatic function:
- Total bilirubin ≤ 1.5 X ULN
- AST (SGOT) ≤ 2.5 X ULN
- ALT (SGPT) ≤ 2.5 X ULN
- Adequate renal function as determined by either:
- Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used)
- Serum creatinine ≤ 1.5 X ULN
- Ability to swallow oral medications
- Ability to understand the nature of this study protocol and give written informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Any prior systemic or investigational therapy for metastatic or locally advanced pancreatic cancer or biliary cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permissible as long as it was completed > 6 months prior to the time of study enrollment.
- Inability to comply with study and/or follow-up procedures.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
- Presence of central nervous system or brain metastases.
- Pregnancy (positive pregnancy test) or lactation.
- Prior malignancy except for adequately treated basal 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 form of cancer from which the patient has been disease-free for 5 years.
Show all 11Show fewer
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Known, existing uncontrolled coagulopathy.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Concurrent/pre-existing use of coumadin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Huntsman Cancer Center, University of Utah
Salt Lake City, Utah, 84112
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Phase I Study, With Expanded Cohort, of Biweekly Fixed-dose Rate Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic and Biliary Carcinomas
The purpose of this study is to find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These two drugs used together are considered an acceptable standard of care for pancreatic and biliary cancers. However, in this study the dose and dosing schedule will be changed, in the hopes that the drugs will have more effect with fewer side effects than when given in the standard way.
- Conditions
- Pancreatic Cancer, Biliary Cancer
- Being tested
- gemcitabine, capecitabine
- Keywords
- pancreatic cancer, biliary cancer, gemcitabine, capecitabine
- Medical subject headings
- Pancreatic Neoplasms, 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 gemzar
1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days)
capecitabineDrug
Also called xeloda
starting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days)
| Study group | Role | What they receive |
|---|---|---|
| Gem/Cape | Experimental | Not described Receives: Drug: gemcitabine; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the maximum tolerated dose of fixed-dose rate gemcitabine plus capecitabine given by biweekly administration in patients with advanced pancreatic and biliary tract malignancies.
Measured: 2 years
Secondary outcomes (5)
Objective response rate (ORR) and disease control rate (DCR) in patients with measurable disease at baseline
Measured: 2 years
Biomarker (CA19-9) response rate (decline by ≥ 50%) in patients with elevated CA19-9 (≥ 2x ULN) at baseline.
Measured: 2 years
Time to tumor progression (TTP)
Measured: 2 years
Overall survival
Measured: 2 years
Frequency, type, and grade of adverse events using this combination in this patient population
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Andrew Ko, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626158
- Sponsor's protocol ID
- CC#074510
- Status last verified
- Apr 2012
- First submitted
- 14 Feb 2008
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study, With Expanded Cohort, of Biweekly Fixed-dose Rate Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic and Biliary Carcinomas
- ClinicalTrials.gov ID
- NCT00626158
- Acronym / sponsor ID
- CC#074510
- Conditions
- Pancreatic Cancer, Biliary Cancer
- Keywords
- pancreatic cancer, biliary cancer, gemcitabine, capecitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Feb 2008 (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.
The purpose of this study is to find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These two drugs used together are considered an acceptable standard of care for pancreatic and biliary cancers. However, in this study the dose and dosing schedule will be changed, in the hopes that the drugs will have more effect with fewer side effects than when given in the standard way.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gem/Cape | Experimental | Drug: gemcitabine, Drug: capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically-confirmed pancreatic adenocarcinoma or biliary tract carcinoma (cholangiocarcinoma or gallbladder cancer)
- Disease must not be amenable to surgical resection. Patients with either locally advanced or metastatic disease are eligible
- No prior systemic therapy for their diagnosis
- ECOG performance score of 0-1
- Evidence of either or both of the following:
Key exclusion criteria (11 listed)
- Any prior systemic or investigational therapy for metastatic or locally advanced pancreatic cancer or biliary cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permissible as long as it was completed > 6 months prior to the time of study enrollment.
- Inability to comply with study and/or follow-up procedures.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
- Presence of central nervous system or brain metastases.
- Pregnancy (positive pregnancy test) or lactation.
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: gemzar1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days) | Drug | Gem/Cape |
| capecitabineAlso: xelodastarting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days) | Drug | Gem/Cape |
Primary outcome
To establish the maximum tolerated dose of fixed-dose rate gemcitabine plus capecitabine given by biweekly administration in patients with advanced pancreatic and biliary tract malignancies.
Time frame: 2 years
5 secondary outcomes
Objective response rate (ORR) and disease control rate (DCR) in patients with measurable disease at baseline
Time frame: 2 years
Biomarker (CA19-9) response rate (decline by ≥ 50%) in patients with elevated CA19-9 (≥ 2x ULN) at baseline.
Time frame: 2 years
Time to tumor progression (TTP)
Time frame: 2 years
Overall survival
Time frame: 2 years
Frequency, type, and grade of adverse events using this combination in this patient population
Time frame: 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 4 Apr 2012.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Andrew Ko, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gemcitabine and capecitabine in people with Pancreatic Cancer and Biliary Cancer, run by University of California, San Francisco at 2 sites 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 22 inclusion and 11 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 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To establish the maximum tolerated dose of fixed-dose rate gemcitabine plus capecitabine given by biweekly administration in patients with advanced pancreatic and biliary tract malignancies. (time frame: 2 years). 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 4 Apr 2012.