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A Feasibility Study for Individualized Treatment of Patients With Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Feasibility Study for Individualized Treatment of Patients With Advanced Pancreatic Cancer


- Establish tumor xenografts from patients with resectable adenocarcinoma of the pancreas
who undergo surgical resection at Johns Hopkins Hospital.

- Determine the activity of a series of 10 anticancer drugs against these tumors in ex
vivo studies.

- Determine the response rate, time to treatment failure, and 6-month survival rate in
patients whose tumors were xenografted and treated in the mouse when treated with the
most active agent identified in that model.

- Define determinants of susceptibility and resistance to the drugs in xenografted


- Part I (surgical resection, tumor xenografts generation, and drug selection): Patients
undergo surgical resection. The resected tumor tissue is implanted in laboratory mice
to generate tumor xenografts. The mice are then treated with a series of 10 approved
anticancer drugs, whose anticancer activity are ranked from the most to the least
effective based on response of the tumor xenografts. The most effective drug is
identified for the individual patient. Patients for whom no drug is found to be
effective are removed from the study. Patients who develop progressive disease after
surgical resection and after mice data is available proceed to part II.

- Part II (individual patient treatment): Patients receive the most effective drug
identified in part I in the absence of disease progression or unacceptable toxicity.
The drugs may include bortezomib, capecitabine, cetuximab, docetaxel, erlotinib
hydrochloride, gemcitabine hydrochloride, irinotecan hydrochloride, mitomycin C,
sirolimus, or thalidomide.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


- Suspected adenocarcinoma of the pancreas with resectable disease (part I)

- Scheduled to have surgical resection at the Johns Hopkins Hospital

- Participation in part I of the study with informative mouse xenograft data (part II)

- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
not amenable to curative treatment (part II)

- The following diagnoses are ineligible:

- Adenosquamous cell

- Islet cell

- Cystadenoma or cystadenocarcinoma

- Carcinoid

- Small or large cell carcinoma or lymphoma

- Patient is ineligible if any of the following occur (part II):

- Xenograft data is noninformative

- Tumors do not take in the mice or do not respond to any of the selected agents

- Disease progression occurs before mice data is available

- No adenocarcinoma arising from a site other than the pancreas (e.g., distal common
bile duct, ampulla of vater, or periampullary duodenum)

- No known brain metastases


- ECOG performance status 0 or 1

- Life expectancy > 12 weeks

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study

- WBC > 3,500/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Creatinine ≤ 2 mg/dL

- Bilirubin ≤ 2 mg/dL

- ALT, AST, and alkaline phosphatase ≤ 5 times upper limit of normal

- No uncontrolled medical conditions that could potentially increase the risk of toxic
effects or complications when treated with chemotherapy

- No gastrointestinal tract disease resulting in an inability to take oral medication

- No disease requiring IV alimentation

- No active peptic ulcer disease

- No active infections

- No history of another neoplasm except for nonmetastatic, nonmelanoma skin cancers ≤ 5
years prior to enrollment

- No unresolved chronic toxicity (except alopecia) > grade 2 from previous anticancer

- Patients must not have documented history of clinically significant cardiovascular
disease including any of the following:

- Myocardial infarction within the past 12 months

- Unstable angina

- Peripheral vascular disease ≥ grade 2

- Uncontrolled congestive heart failure

- Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 170 mm Hg and/or
diastolic BP > 95 mm Hg)

- HIV negative

- Hepatitis B and C negative


- No prior treatment for recurrent disease

- More than 30 days since prior chemotherapy

- More than 4 weeks since prior surgery (excluding minor procedures, dental work, skin
biopsy, etc.)

- No prior surgical procedures affecting absorption

Type of Study:


Study Design:

Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month survival

Outcome Description:

To determine the 6 months actuarial survival of patients whose tumors were xenografted and treated in the mouse when treated with the most active agent identified in that model

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Daniel A. Laheru, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:

JHOC-J0507, CDR0000455000



Start Date:

October 2005

Completion Date:

April 2010

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • Pancreatic Neoplasms