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A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Stage IV Pancreatic Cancer

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Trial Information

A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer

The investigators in the PCRT team have developed a therapeutic regimen which attacks both
the tumor compartment and the stromal compartment of pancreatic cancer and induces complete
responses in a small percentage of patients with advanced stage IV pancreatic cancer.

The gemcitabine + nab-paclitaxel regimen had outstanding activity in a 67 patient phase I/II
trial with all patients at the recommended phase II doses (n=44) having a decrease in
CA19-9, some complete responses and a median survival of 12.2 months. The proposed regimen
that is devised for this study is a bold, innovative approach with the specific aim of
utilizing a relentless pursuit approach to try to make the complete response rate >70% and
have this response be durable (which the PCRT has defined as lasting at least 6 months) and
to dramatically enhance the percent of patients who survive one year (try to make the rate

The induction regimen the investigators propose collapses the stroma (gemcitabine +
nab-paclitaxel) and addresses the use of a non-cross resistant active regimen (FOLFIRINOX)
as a consolidation regimen. Both should improve the chance of driving tumor markers down
dramatically. The investigators think that FOLFIRINOX with the stromal collapse induced by
the initial regimen, plus the totally non-cross resistant shot against the disease
(consolidation), will maximize the chance of achieving a complete response with an attendant
improvement in survival.

After the consolidation, the patient will be maintained on a less toxic targeted therapy
selected by molecular profiling plus the use of the antimetabolomic agent metformin which
has consistently been associated with better survival in multiple retrospective studies
(Jiralerspong et al., 2009).

Inclusion Criteria:

- Histologically documented Stage IV metastatic adenocarcinoma of the pancreas with
measurable disease

- Performance status ECOG 0 or 1

- Patients may not have received prior treatment for metastatic pancreatic
adenocarcinoma except for receiving gemcitabine or 5FU as a radiosensitizer along
with radiation therapy; or have received gemcitabine for adjuvant treatment if they
have been off gemcitabine for > 12 months

- Adult (>18 years of age) male or non-pregnant and non-lactating female

- A negative serum pregnancy test (Beta-hCG) documented within 72 hours of the first
administration of study drug in female patients of child-bearing potential

- Agreement to use contraception considered adequate and appropriate by the

- The following blood counts at baseline:

- ANC >/= 1.5 x 109/L

- Hgb > 9g/dL

- Platelets >100 x 109/L

- The following blood chemistry levels at baseline:

- AST and ALT metastasis are present

- Bilirubin
- Serum creatinine within 1.5 x ULN

- PT, INR within 1.5 x ULN unless on therapeutic doses of warfarin

- Must have measurable disease outside the pancreas by RECIST criteria

- No clinically significant abnormalities in urinalysis results

- Voluntary agreement to participate in this study after being informed about the
nature of the study including potential risks and benefits and having the ability to
have questions addressed. The patient must sign and date the IRB approved Informed
Consent Form (ICF) prior to participation in any study-related procedures

Exclusion Criteria:

- Has pancreatic islet cell neoplasms

- Is pregnant or lactating

- Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic

- Known infection with HIV, Hepatitis B or Hepatitis C.

- Patient with a history of interstitial lung disease, history of slowly progressive
dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary
fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies (see section

- Has a serious medical risk factor(s) involving any of the major organ systems such
that the investigator considers it unsafe for the patient to receive an experimental
research drug.

- Is unwilling or unable to comply with study procedures.

- Is enrolled in any other investigational trial.

Caution of observation for interstitial pneumonitis in patients prior to enrollment:

Before enrollment, evaluate candidate patients fro familial, environmental or occupational
exposure to opportunistic pathogens, and do not enroll those with a history of slowly
progressive dyspnea and unproductive cough, or of conditions such as sarcoidosis,
silicosis. idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or
multiple allergies.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Response Rate

Outcome Description:

The primary objectives of this study are to relentlessly pursue treatment for 34 individual patients with Stage IV pancreatic cancer to obtain: • The complete response rate (as defined by a complete metabolomic response (CMR) of SUV normalization from baseline, OR a complete response on CT scan using a modified RECIST criteria and CA 19-9 (or CA 125, CEA, or PAM4 if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN).

Outcome Time Frame:

1 yr.

Safety Issue:


Principal Investigator

Ramesh K Ramanathan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Translational Genomics Research Institute, Phoenix, Arizona.


United States: Institutional Review Board

Study ID:

PCRT 11-002



Start Date:

November 2011

Completion Date:

August 2014

Related Keywords:

  • Stage IV Pancreatic Cancer
  • pancreatic cancer
  • pancreatic adenocarcinoma
  • Stage IV pancreatic cancer
  • pancreas
  • pancreatic
  • Pancreatic Neoplasms



Virginia Mason Medical CenterSeattle, Washington  98111
Evergreen Hematology And OncologySpokane, Washington  99218
Disney Family Cancer CenterBurbank, California  91505
TGen Clinical Research Services (TCRS)Scottsdale, Arizona  85258
Virginia Piper Cancer Institute (VPCI)Minneapolis, Minnesota  55407