Molecularly Tailored Therapy for Pancreas Cancer

April 6, 2018 updated by: Georgetown University

A Pilot Study of Molecularly Tailored Therapy for Patients With Metastatic Pancreatic Cancer

Patient therapy is tailored according to the molecular profile of the patient's tumor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is for patients with metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to determine whether molecularly tailored therapy can improve the effectiveness of standard chemotherapy combinations for patients with metastatic pancreatic cancer. A series of special tests will be performed on a sample of tumor, and based on the results subjects will be assigned to one of seven chemotherapy treatments, with each being the combination of two standard chemotherapies. Each of these combinations has been safely used in patients with pancreatic or other types of cancer. The purpose of this study is to to determine the ability to personalize therapy in this manner, and to determine how many patients a larger study would need. A second purpose is not to determine if one doublet is better than another. Rather, this second purpose is to show that for all patients enrolled in this protocol who have been assigned a doublet based on their tumor's molecular analysis (molecular tailoring), treatment response will be better than would be expected compared to patients who have been treated in the past with no molecular tailoring.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University- Lombardi Comprehensive Cancer Center
    • Maryland
      • Olney, Maryland, United States, 20832
        • Medstar Montgomery Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven pancreatic adenocarcinoma with measurable disease
  • Biopsy accessible tumor deposits
  • ECOG performance status 0-2
  • Age >/= 18 years
  • Subjects with no brain metastases or history of previously treated brain metastases
  • Adequate hepatic, renal, and bone marrow function
  • Partial thromboplastin time must be </= 1.5 x upper normal limit of institution's normal range and INR < 1.5
  • Life expectancy > 12 weeks
  • Women of childbearing potential must have a negative seum pregnancy test within 14 days prior to initiation of treatment
  • Subject is capable of understanding and complying with parameters as outlines in the protocol and able to sign and date the consents

Exclusion Criteria:

  • CNS metastases which do not meet criteria outlines in inclusion criteria
  • Active severe infection or known chronic infection with HIV or hepatitis B virus
  • Cardiovascular disease
  • Life threatening visceral disease or other severe concurrent disease
  • Women who are pregnant, breastfeeding, or women of childbearing potential not using dual forms of effective contraception
  • Anticipated patient survival under 3 months
  • Patients receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to gemcitabine, oxaliplatin, 5-FU, docetaxel or irinotecan
  • Uncontrolled intercurrent illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Modified FOLFOX-6
Oxaliplatin 85 mg/m2 day 1 and 5-fluorouracil 400 mg/m2 day 1 and Leucovorin 400 mg/m2 day 1 and 5-fluorouracil 2400 mg/m2 over 46 hours on day 1-3 of every 14 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed
Drug: Modified FOLFOX-6
Other Names:
  • 5-FU
  • Eloxatin
  • Leucovorin
  • Oxaliplatin
  • 5-Fluorourcil
EXPERIMENTAL: Ox-Tax
Docetaxel 65 mg/m2 and Oxaliplatin 100 mg/m2 on day 1 every 3 weeks All drugs will be administered until disease progression or unacceptable toxicity are observed
Drug: Ox-Tax
Other Names:
  • Taxotere
  • Eloxatin
  • Docetaxel
  • Oxalipaltin
EXPERIMENTAL: FOLFIRI
Irinotecan 180 mg/m2 on day 1 and 5-FU 400 mg/m2 on day 1 and Leucovorin 400 mg/m2 day 1 and 5-FU 2400 mg/m2 over 46 hours, days 1-3 as a continuous infusion All drugs will be administered until disease progression or unacceptable toxicity are observed
Drug: FOLFIRI
Other Names:
  • 5-FU
  • Leucovorin
  • Irinotecan
  • 5-Fluorouracil
  • CPT-11
EXPERIMENTAL: Tax-Iri
2 weeks on, 1 week off of Docetaxel 35 mg/m2/week and Irinotecan 50 mg/m2/week Both administered on day 1 of each week of treatment All drugs will be administered until disease progression or unacceptable toxicity are observed
Drug: Tax-Iri
Other Names:
  • Taxotere
  • Irinotecan
  • CPT-11
  • Docetaxel
EXPERIMENTAL: Gem-Ox
Gemcitabine: 1000 mg/m2 over 100 minutes on Day 1 Oxaliplatin: 100 mg/m2 over 120 minutes on Day 2 of every 14 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed
Drug: Gem-OX
Other Names:
  • Gemzar
  • Gemcitabine
  • Eloxatin
  • Oxaliplatin
EXPERIMENTAL: Gem-5FU
Gemcitabine: 1000 mg/m2 over 30 minutes 5-FU 2000/m6 as a 24 hour infusion on days 1, 8, and 15 of every 28 day cycle All drugs will be administered until disease progression or unacceptable toxicity are observed
Drug: Gem-5FU
Other Names:
  • Gemzar
  • Gemcitabine
  • 5-FU
  • 5-fluorouracil
EXPERIMENTAL: Gem-Tax
Gemcitabine 1000 mg/m2 over 30 minutes and Docetaxel 35 mg/m2 over 60 minutes on days 1, 8, and 15 of every 28 day cycle
Drug: Gem-Tax
Other Names:
  • Gemzar
  • Gemcitabine
  • taxotere
  • Docetael

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of biopsy and treatment
Time Frame: 1 year
The number of days from study entry to biopsy to molecular results to first dose
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimates for future trials
Time Frame: 1 year
objective response rate, proportions of patients with each molecular profile, timing of biopsy and therapy results, usefulness of molecular profile results and adverse events.
1 year
Clinical Benefit
Time Frame: 1 year
confirmed classification of stable disease, partial response, or complete response
1 year
Progression-free survival
Time Frame: 1 year
Time in days from study entry until progression or death
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Investigators

  • Principal Investigator: Michael Pishvaian, MD, Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

January 24, 2018

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (ESTIMATE)

June 28, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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