Molecularly Tailored Therapy for Pancreas Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888978
• Other study ID #: 2011-384
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2013
• Last updated: April 6, 2018
• Start date: December 2012
• Est. completion date: January 24, 2018

Study information

• Verified date: July 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 24, 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gem-OX

• Gem-5FU

• Gem-Tax

• Modified FOLFOX-6

• Ox-Tax

• FOLFIRI

• Tax-Iri

Locations

Country	Name	City	State
United States	MedStar Montgomery Medical Center	Olney	Maryland
United States	Georgetown University- Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timing of biopsy and treatment	The number of days from study entry to biopsy to molecular results to first dose	1 year
Secondary	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.	1 year
Secondary	Clinical Benefit	confirmed classification of stable disease, partial response, or complete response	1 year
Secondary	Progression-free survival	Time in days from study entry until progression or death	1 year