Clinical trial NCT01888978: Molecularly Tailored Therapy for Pancreas Cancer
Official title: A Pilot Study of Molecularly Tailored Therapy for Patients With Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreas
cancer
metastatic
chemotherapy
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Timing of biopsy and treatment
timeFrame: 1 year
Secondary outcomes:
measure: Estimates for future trials
timeFrame: 1 year
measure: Clinical Benefit
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University- Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Olney
country: United States
facility: MedStar Montgomery Medical Center
state: Maryland
Study officials:
affiliation: Georgetown University
name: Michael Pishvaian, MD
role: PRINCIPAL_INVESTIGATOR
References: