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Molecularly Tailored Therapy for Pancreas Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888978
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Georgetown University

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : January 24, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Timing of biopsy and treatment [ Time Frame: 1 year ]
    The number of days from study entry to biopsy to molecular results to first dose


Secondary Outcome Measures :
  1. 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.

  2. Clinical Benefit [ Time Frame: 1 year ]
    confirmed classification of stable disease, partial response, or complete response

  3. Progression-free survival [ Time Frame: 1 year ]
    Time in days from study entry until progression or death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888978


Locations
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United States, District of Columbia
Georgetown University- Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
United States, Maryland
MedStar Montgomery Medical Center
Olney, Maryland, United States, 20832
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Michael Pishvaian, MD Georgetown University
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01888978    
Other Study ID Numbers: 2011-384
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: July 2017
Keywords provided by Georgetown University:
Pancreas
cancer
metastatic
chemotherapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Gemcitabine
Fluorouracil
Docetaxel
Oxaliplatin
Irinotecan
Levoleucovorin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Topoisomerase I Inhibitors
Topoisomerase Inhibitors