AzTrials
AzTrials

Pancreatic CancerPhase 2NCT01888978

Molecularly Tailored Therapy for Pancreas Cancer

A Phase 2 study testing Gem-OX, Gem-5FU and Gem-Tax in people with Pancreatic Cancer, run by Georgetown University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Patient therapy is tailored according to the molecular profile of the patient's tumor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gem-OX, Gem-5FU and Gem-Tax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
2 sitesUnited States
Study dates
Dec 2012to 24 Jan 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • MedStar Montgomery Medical Center

    Olney, Maryland, 20832

  • Georgetown University- Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Gem-OX, Gem-5FU, Gem-Tax, Modified FOLFOX-6, Ox-Tax
Keywords
Pancreas, cancer, metastatic, chemotherapy
Medical subject headings
Pancreatic Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gem-OXDrug

    Also called Gemcitabine, Gemzar, Oxaliplatin, Eloxatin

  • Gem-5FUDrug

    Also called Gemcitabine, Gemzar, 5-FU, 5-fluorouracil

  • Gem-TaxDrug

    Also called Gemcitabine, Gemzar, Docetael, taxotere

  • Modified FOLFOX-6Drug

    Also called Oxaliplatin, Eloxatin, 5-FU, 5-Fluorourcil

  • Ox-TaxDrug

    Also called Docetaxel, Taxotere, Oxalipaltin, Eloxatin

  • FOLFIRIDrug

    Also called Irinotecan, CPT-11, 5-FU, 5-Fluorouracil

  • Tax-IriDrug

    Also called Docetaxel, Taxotere, Irinotecan, CPT-11

Study groups in NCT01888978
Study groupRoleWhat they receive
Modified FOLFOX-6ExperimentalOxaliplatin 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
Receives: Drug: Modified FOLFOX-6
Ox-TaxExperimentalDocetaxel 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
Receives: Drug: Ox-Tax
FOLFIRIExperimentalIrinotecan 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
Receives: Drug: FOLFIRI
Tax-IriExperimental2 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
Receives: Drug: Tax-Iri
Gem-OxExperimentalGemcitabine: 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
Receives: Drug: Gem-OX
Gem-5FUExperimentalGemcitabine: 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
Receives: Drug: Gem-5FU
Gem-TaxExperimentalGemcitabine 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
Receives: Drug: Gem-Tax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timing of biopsy and treatment

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

    Measured: 1 year

Secondary outcomes (3)

  1. 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.

    Measured: 1 year

  2. Clinical Benefit

    confirmed classification of stable disease, partial response, or complete response

    Measured: 1 year

  3. Progression-free survival

    Time in days from study entry until progression or death

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionJun 2016
  4. Study completion24 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01888978
Sponsor's protocol ID
2011-384
Status last verified
Jul 2017
First submitted
26 Jun 2013
Last updated
9 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gem-OX, Gem-5FU and Gem-Tax in people with Pancreatic Cancer, run by Georgetown University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timing of biopsy and treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01888978.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in