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Active, not recruitingNCT01660971Updated Sep 9, 2026

Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery

A Phase 1 interventional study of Dasatinib and Erlotinib Hydrochloride in Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma and Stage III Pancreatic Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI). Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (also phase II recommended dose) of the combination of gemcitabine (gemcitabine hydrochloride), erlotinib (erlotinib hydrochloride) and dasatinib in patients with advanced pancreatic adenocarcinoma.

SECONDARY OBJECTIVES:

I. To determine the safety profile of the combination of gemcitabine, erlotinib and dasatinib.

II. To evaluate the response rate and response duration of advanced pancreatic adenocarcinoma treated with dasatinib, erlotinib and gemcitabine.

III. To determine progression-free survival and overall survival for this group of patients.

IV. To determine the utility of advanced magnetic resonance imaging techniques to assess in vivo effects of therapy (changes in tumor vascularity, cellularity).

V. To assess the use of serum markers as predictors of response and outcome.

OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride and dasatinib.

Patients receive gemcitabine hydrochloride intravenously (IV) over 30-60 minutes on days 1, 8, and 15, and dasatinib orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 4 weeks thereafter.

02

Conditions studied

  • Metastatic Pancreatic Adenocarcinoma
  • Recurrent Pancreatic Carcinoma
  • Stage III Pancreatic Cancer AJCC v6 and v7
  • Stage IV Pancreatic Cancer AJCC v6 and v7
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 19 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Patients with known brain metastases
  • 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
  • Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with erlotinib or dasatinib
  • Patients with immune deficiency are excluded
  • Patients on potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and inhibitors
  • 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
  • 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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Treatment (gemcitabine, dasatinib, erlotinib)

    Patients receive gemcitabine hydrochloride IV over 30-60 minutes on days 1, 8, and 15, and dasatinib PO QD and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Drug: Dasatinib · Drug: Erlotinib Hydrochloride · Drug: Gemcitabine Hydrochloride

Interventions

  • DrugDasatinib

    Given PO

    Also known as: BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel

  • DrugErlotinib Hydrochloride

    Given PO

    Also known as: CP 358, CP-358, Cp-358,774, CP358, OSI 774, OSI-774, OSI774, Tarceva

  • DrugGemcitabine Hydrochloride

    Given IV

    Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY 188011, LY-188011, LY188011

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose of gemcitabine hydrochloride and dasatinib given together with erlotinib hydrochloride, determined by incidence of dose-limiting toxicity graded according to NCI CTCAE v 4.0

    Time frame: Up to 4 weeks after completion of study treatment

Secondary outcomes

  1. Overall survival (OS)

    The OS curves will be estimated by the Kaplan-Meier method. Median OS and its 95% confidence intervals will be estimated.

    Time frame: The time from enrollment until the time of death due to any cause, assessed up to 6 years

  2. Progression free survival (PFS)

    The PFS curves will be estimated by the Kaplan-Meier method. Median PFS and its 95% confidence intervals will be estimated.

    Time frame: The time from enrollment until the first occurrence of radiographic or clinical evidence of disease progression or death due to any cause, assessed up to 6 years

  3. Response rate, assessed according to RECIST

    The response rate and its 95% confidence interval will be calculated using the exact binominal method.

    Time frame: Up to 6 years

  4. Response duration

    The response duration for the responders will be summarized using mean, median and standard deviation.

    Time frame: The time from when measurement criteria are met for complete response or partial response (whichever is first recorded) until the date that recurrent or progressive disease is objectively documented, assessed up to 6 years

  5. Serious and other significant adverse events (AEs), graded according to NCI CTCAE v 4.0

    The patient incidence of AEs will be summarized by preferred term, severity and relationship to study drug. Cross tabulations will be provided to summarize frequencies of abnormalities.

    Time frame: Up to 30 days after completion of study treatment

07

Study locations

1 site
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37232, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01660971
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 9, 2012
Start date
Jul 30, 2012
Primary completion
Sep 6, 2017
Completion
Mar 31, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Dana B Cardin
principal investigator · Vanderbilt University/Ingram Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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