Molecularly Tailored Therapy for Pancreas Cancer

Sponsor

Georgetown University (Other)

Overall Status

Completed

CT.gov ID

NCT01888978

Collaborator

(none)

Enrollment

Locations

Arms

61.8

Duration (Months)

9.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Gem-OX Drug: Gem-5FU Drug: Gem-Tax Drug: Modified FOLFOX-6 Drug: Ox-Tax Drug: FOLFIRI Drug: Tax-Iri	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jan 24, 2018

Arms and Interventions

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: Oxaliplatin Eloxatin 5-FU 5-Fluorourcil Leucovorin
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: Docetaxel Taxotere Oxalipaltin Eloxatin
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: Irinotecan CPT-11 5-FU 5-Fluorouracil Leucovorin
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: Docetaxel Taxotere Irinotecan CPT-11
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: Gemcitabine Gemzar Oxaliplatin Eloxatin
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: Gemcitabine Gemzar 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: Gemcitabine Gemzar Docetael taxotere

Outcome Measures

Primary Outcome Measures

Timing of biopsy and treatment [1 year]
The number of days from study entry to biopsy to molecular results to first dose

Secondary Outcome Measures

Estimates for future trials [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.
Clinical Benefit [1 year]
confirmed classification of stable disease, partial response, or complete response
Progression-free survival [1 year]
Time in days from study entry until progression or death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University- Lombardi Comprehensive Cancer Center	Washington	District of Columbia	United States	20007
2	MedStar Montgomery Medical Center	Olney	Maryland	United States	20832