search
Back to results

Molecularly Tailored Therapy for Pancreas Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gem-OX
Gem-5FU
Gem-Tax
Modified FOLFOX-6
Ox-Tax
FOLFIRI
Tax-Iri
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreas, cancer, metastatic, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University- Lombardi Comprehensive Cancer Center
  • MedStar Montgomery Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Modified FOLFOX-6

Ox-Tax

FOLFIRI

Tax-Iri

Gem-Ox

Gem-5FU

Gem-Tax

Arm Description

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Timing of biopsy and treatment
The number of days from study entry to biopsy to molecular results to first dose

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2013
Last Updated
April 6, 2018
Sponsor
Georgetown University
search

1. Study Identification

Unique Protocol Identification Number
NCT01888978
Brief Title
Molecularly Tailored Therapy for Pancreas Cancer
Official Title
A Pilot Study of Molecularly Tailored Therapy for Patients With Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreas, cancer, metastatic, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified FOLFOX-6
Arm Type
Experimental
Arm Description
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
Arm Title
Ox-Tax
Arm Type
Experimental
Arm Description
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
Arm Title
FOLFIRI
Arm Type
Experimental
Arm Description
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
Arm Title
Tax-Iri
Arm Type
Experimental
Arm Description
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
Arm Title
Gem-Ox
Arm Type
Experimental
Arm Description
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
Arm Title
Gem-5FU
Arm Type
Experimental
Arm Description
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
Arm Title
Gem-Tax
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gem-OX
Other Intervention Name(s)
Gemcitabine, Gemzar, Oxaliplatin, Eloxatin
Intervention Type
Drug
Intervention Name(s)
Gem-5FU
Other Intervention Name(s)
Gemcitabine, Gemzar, 5-FU, 5-fluorouracil
Intervention Type
Drug
Intervention Name(s)
Gem-Tax
Other Intervention Name(s)
Gemcitabine, Gemzar, Docetael, taxotere
Intervention Type
Drug
Intervention Name(s)
Modified FOLFOX-6
Other Intervention Name(s)
Oxaliplatin, Eloxatin, 5-FU, 5-Fluorourcil, Leucovorin
Intervention Type
Drug
Intervention Name(s)
Ox-Tax
Other Intervention Name(s)
Docetaxel, Taxotere, Oxalipaltin, Eloxatin
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Other Intervention Name(s)
Irinotecan, CPT-11, 5-FU, 5-Fluorouracil, Leucovorin
Intervention Type
Drug
Intervention Name(s)
Tax-Iri
Other Intervention Name(s)
Docetaxel, Taxotere, Irinotecan, CPT-11
Primary Outcome Measure Information:
Title
Timing of biopsy and treatment
Description
The number of days from study entry to biopsy to molecular results to first dose
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Estimates for future trials
Description
objective response rate, proportions of patients with each molecular profile, timing of biopsy and therapy results, usefulness of molecular profile results and adverse events.
Time Frame
1 year
Title
Clinical Benefit
Description
confirmed classification of stable disease, partial response, or complete response
Time Frame
1 year
Title
Progression-free survival
Description
Time in days from study entry until progression or death
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Pishvaian, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University- Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
MedStar Montgomery Medical Center
City
Olney
State/Province
Maryland
ZIP/Postal Code
20832
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Molecularly Tailored Therapy for Pancreas Cancer

We'll reach out to this number within 24 hrs