NCT01660971Active, not recruitingPhase 1
Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
A Phase 1 Study of Gemcitabine, Dasatinib and Erlotinib in Patients With Advanced Pancreatic Carcinoma
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and dasatinib when given together with erlotinib hydrochloride in treating patients with pancreatic cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dasatinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and dasatinib together with erlotinib hydrochloride may kill more tumor cells.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 7 Aug 2012
- Start date
- 30 Jul 2012
- Primary completion date
- 6 Sept 2017
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Pancreatic cancer
- NCT number
- NCT01660971
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 19
- From 30 Jul 2012 to the primary completion date, 6 Sept 2017
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (with the exception of alopecia and neuropathy); no radiation is allowed on study
- Patients who are receiving any other investigational agents
- Major surgical procedure within 4 weeks of treatment
- Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with erlotinib or dasatinib
- Patients on potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and inhibitors
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, erlotinib or gemcitabine
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Malabsorption syndrome or other condition that would interfere with intestinal absorption
- Other active malignancy (with the exception of locally treated non-melanoma skin cancers)
- Human immunodeficiency virus (HIV) positive patients who are on combination antiretroviral therapy
Lab values
- Patients may not have any clinically significant cardiovascular disease including the following:
- Myocardial infarction or ventricular tachyarrhythmia within 6 months
- Prolonged corrected QT (QTc) \> 480 msec (Fridericia correction)
- Known ejection faction less than institutional normal
- Major conduction abnormality (unless a cardiac pacemaker is present)
Other
- Patients with known brain metastases
- Patients with immune deficiency are excluded
Who the study is looking for
- Cytologically or histologically confirmed pancreatic adenocarcinoma (excluding islet cell or ampullary tumors) that is metastatic or unresectable
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Patients may have received prior chemotherapy for advanced disease as long as it did not include gemcitabine; if patients received prior adjuvant therapy including gemcitabine, patients must be \> 6 months from the last dose of gemcitabine; patients must have recovered from side effects of prior therapy to grade =\< 1 as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0
- Patients may have received prior radiation presuming \> 4 weeks since last dose and measurable disease outside the radiation field
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
- Anticipated life expectancy of greater than 3 months
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin \< 2.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic pyruvate transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal OR =\< 5 x institutional upper limit of normal when liver metastases are present
- Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Patients must be able to swallow pills
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.