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Pancreatic CancerPhase 1/2NCT00948688

Vorinostat With XRT and 5-FU for Locally Advanced Adenocarcinoma of the Pancreas

A Phase 1/2 study testing Radiation therapy, 5-FU and Vorinostat in people with Pancreatic Cancer and Adenocarcinoma of the Pancreas, run by Massachusetts General Hospital at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The durg vorinostat (Zolinza) is a type of drug called an histone deacetylase (HDAC) inhibitor. It inhibits a group of enzymes called histone deacetylases. These enzymes help cancer cells survive. By inhibiting these enzymes, vorinostat helps kill cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiation therapy, 5-FU and Vorinostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
Aug 2009to Nov 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 or cytologically proven adenocarcinoma of the pancreas
  • Evaluable disease
  • Must have received 3-4 months of gemcitabine-based chemotherapy and have had stable disease by RECIST criteria. Regimens include:
  • gemcitabine alone
  • gemcitabine and erlotinib
  • gemcitabine and oxaliplatin
Show all 15Show fewer
  • gemcitabine and cisplatin
  • gemcitabine and capecitabine
  • 18 years of age or older
  • Life expectancy of greater than 4 months
  • ECOG Performance Status 0-1
  • Normal organ and marrow function as outlined in the protocol
  • Ability to drink at least 2 liters of fluid daily
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
  • Patients must be able to swallow capsules

Who cannot join

  • Chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Participants may not be receiving any other study agents
  • Known distant metastases to any organ
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or 5-FU
  • Patients taking warfarin due to potential interactions of both 5-FU and vorinostat. Low molecular weight heparin should be substituted when appropriate
  • Patients who have received upper abdominal radiation therapy which fields would overlap with that determined necessary to treat the primary tumor.
Show all 11Show fewer
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding women
  • Individuals with history of a different malignancy are ineligible unless they are deemed by the investigator to be at low risk of recurrence of that malignancy. Patients may not have a concurrent second malignancy.
  • Active HIV or hepatitis
  • Prior exposure to HDAC inhibitor (except valproic acid, provided there is a 30 day washout period)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Phase 1/2 Study of Vorinostat in Combination With Radiation Therapy and Infusional 5-FU in Patients With Locally Advanced Adenocarcinoma of the Pancreas

The durg vorinostat (Zolinza) is a type of drug called an histone deacetylase (HDAC) inhibitor. It inhibits a group of enzymes called histone deacetylases. These enzymes help cancer cells survive. By inhibiting these enzymes, vorinostat helps kill cancer cells. In this research study vorinostat will be given along with radiation therapy and the drug 5-FU. This is the first research study in which vorinostat will be given along with radiation therapy and 5-FU. The purpose of this research study is to find the highest dose of vorinostat that can be given safely along with radiation therapy and 5-FU. The investigators will also begin to get information about whether vorinostat combined with radiation and 5-FU may help to treat pancreatic cancer.

Read the detailed description
  • Since we are looking for the highest dose of vorinostat that can be administered safely without severe or unmanageable side effects, not everyone who participates will receive the same dose. The dose will depend upon the number of participants enrolled on the study and how well they have tolerated their doses.
  • 5-FU will be given intravenously over 24 hours 7 days per week during each week of radiation therapy. In order for participants to be able to receive the 5-FU as an outpatient, they will need to have central line catheter placed.
  • Radiation therapy will be given once per day, 5 days per week, for 6 weeks.
  • Vorinostat is taken orally.
  • Participants will be seen once per week during the 6 weeks that they are receiving 5-FU, radiation therapy and vorinostat.
Being tested
Radiation therapy, 5-FU, Vorinostat
Keywords
Zolinza
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Radiation therapyRadiation

    Once per day, 5 days a week for 6 weeks

  • 5-FUDrug

    Also called Efudex, Carac, Fluoroplex, Adrucil

    Intravenously over 24 hours, 7 days per week during each week of radiation therapy

  • VorinostatDrug

    Also called Zolinza

    Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug

Study groups in NCT00948688
Study groupRoleWhat they receive
Vorinostat, 5-FU, Radiation TherapyExperimentalVorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Receives: Radiation: Radiation therapy; Drug: 5-FU; Drug: Vorinostat

What is being measured

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

  1. Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy.

    The maximum tolerated dose (MTD) is defined as one dose level below the dose level at which participants experience an unacceptable rate of dose-limiting toxicity.

    Measured: 6 weeks

  2. Progression Free Survival (PFS) at 7 Months From Registration

    Progression free survival was defined as the duration of time from registration on study to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.

    Measured: 7 months

Secondary outcomes (5)

  1. Progression Free Survival

    Progression free survival for this endpoint was defined as the duration of time from beginning of the patients' initial chemotherapy to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.

    Measured: 2 years

  2. Number of Participants Experiencing Unacceptable Toxicity

    All participants who receive at least one dose of study treatment were evaluable for toxicity. Unacceptable toxicity is based on the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Most grade 3 (severe) or 4 (life-threatening) events are considered to be unacceptable toxicities -- exceptions include nausea or vomiting, fatigue, and alopecia. Hematologic toxicities need to be either grade 4 or last for protocol-defined durations to be considered unacceptable.

    Measured: 1 year

  3. Overall Survival

    Percentage of participants still alive at 1 year after enrollment on study

    Measured: 1 year

  4. Response Rate

    Participants who have either a complete response (disappearance of all target lesions), partial response (at least 30% decrease in sum of longest diameter of target lesions) or stable disease (decrease in size of less than 30% or increase in size of less than 20%).

    Measured: 1 year

  5. Resectability Rate

    Percentage of patients able to undergo surgical resection after protocol therapy.

    Measured: 5 months

Timeline

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

  1. First posted29 Jul 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionJun 2012
  4. Study completionNov 2013

Why it stopped: Funding was withdrawn after only 10 participants were enrolled

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00948688
Sponsor's protocol ID
09-114
Status last verified
Mar 2017
First submitted
27 Jul 2009
Last updated
10 May 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Tost J, Ak-Aksoy S, Campa D, Corradi C, Farinella R, Ibanez-Costa A, Dubrot J, Earl J, Melian EB, Kataki A, Kolnikova G, Madjarov G, Chaushevska M, Strnadel J, Tanic M, Tomas M, Dubovan P, Urbanova M, Buocikova V, Smolkova B. Leveraging epigenetic alterations in pancreatic ductal adenocarcinoma for clinical applications. Semin Cancer Biol. 2025 Feb;109:101-124. doi: 10.1016/j.semcancer.2025.01.003. Epub 2025 Jan 23.

    PubMed 39863139

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radiation therapy, 5-FU and Vorinostat in people with Pancreatic Cancer and Adenocarcinoma of the Pancreas, run by Massachusetts General Hospital 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 15 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 May 2017. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy. (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT00948688, which also lists 1 linked publication.

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 10 May 2017.

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