Molecularly Tailored Therapy for Pancreas Cancer

NCT01888978 | Completed Phase 2 DMC

• 1 other identifier: 2011-384
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

Pancreas; cancer; metastatic; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Timing of biopsy and treatment

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

  1 year

Secondary Outcomes (3)

• Estimates for future trials

  1 year

• Clinical Benefit

  1 year

• Progression-free survival

  1 year

Study Arms (7)

Modified FOLFOX-6

EXPERIMENTAL

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

Ox-Tax

EXPERIMENTAL

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

FOLFIRI

EXPERIMENTAL

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

Tax-Iri

EXPERIMENTAL

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

Gem-Ox

EXPERIMENTAL

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

Gem-5FU

EXPERIMENTAL

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

Gem-Tax

EXPERIMENTAL

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

Interventions

Gem-OX DRUG

Also known as: Gemcitabine, Gemzar, Oxaliplatin, Eloxatin

Gem-Ox

Gem-5FU DRUG

Also known as: Gemcitabine, Gemzar, 5-FU, 5-fluorouracil

Gem-5FU

Gem-Tax DRUG

Also known as: Gemcitabine, Gemzar, Docetael, taxotere

Gem-Tax

Modified FOLFOX-6 DRUG

Also known as: Oxaliplatin, Eloxatin, 5-FU, 5-Fluorourcil, Leucovorin

Modified FOLFOX-6

Ox-Tax DRUG

Also known as: Docetaxel, Taxotere, Oxalipaltin, Eloxatin

Ox-Tax

FOLFIRI DRUG

Also known as: Irinotecan, CPT-11, 5-FU, 5-Fluorouracil, Leucovorin

FOLFIRI

Tax-Iri DRUG

Also known as: Docetaxel, Taxotere, Irinotecan, CPT-11

Tax-Iri

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (2)

Georgetown University- Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Montgomery Medical Center

Olney, Maryland, 20832, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Gemcitabine; Oxaliplatin; Fluorouracil; Docetaxel; Leucovorin; IFL protocol; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids

Study Officials

• Michael Pishvaian, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: January 24, 2018
• Last Updated: April 9, 2018

Record last verified: 2017-07

Locations

US (2)