AzTrials
AzTrials

Pancreatic CancerPhase 1NCT00983268

Capecitabine, Vorinostat, and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer

A Phase 1 study testing capecitabine, vorinostat and Radiotherapy in people with Pancreatic Cancer and Periampullary Adenocarcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
capecitabine, vorinostat and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Oct 2009to Feb 2013
Phase
Phase 1
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

  • Patient must have histologically confirmed pancreatic or periampullary cancer.
  • Patient must be > 18 years of age.
  • Patient may be resectable, borderline resectable, or unresectable but locally advanced as determined by radiographic examination and consultation with a surgical oncologist.
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
  • Female patients of childbearing potential must be willing to use birth control. The 2 birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy, used throughout the study starting with visit 1. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner) or sponge. Other methods of contraception such as copper intrauterine device or spermicide may be used. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).Female patient of childbearing potential has a negative serum pregnancy test β-hCG within 7 days prior to receiving the first dose of vorinostat.
  • Male patients agree to use an adequate method of contraception for the duration of the study.
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  • Patient has a life expectancy of at least 12 weeks
  • Patient must have adequate organ function as indicated by the following laboratory values:
  • Absolute neutrophil count (ANC) ≥1,500 /mcL
  • Platelets ≥100,000 / mcL Hemoglobin ≥ 9 g/dL
  • Coagulation
  • Prothrombin Time or INR ≤1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation
  • Partial thromboplastin time (PTT) ≤1.2 times the ULN unless the patient is receiving therapeutic anticoagulation.
  • K levels - Normal limits
  • Mg levels - Normal limits
  • Calculated creatinine *clearance ≥20 mL/min
  • Serum total bilirubin ≤ 1.5 X ULN
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
  • Alkaline Phosphatase ≤ 2.5 X ULN
  • Creatinine clearance should be calculated per institutional standard.
  • Patient must be capable of understanding and complying with the study protocol and able to give informed consent.
  • Measurable disease is not an eligibility requirement.

Who cannot join

  • Prior chemotherapy for pancreatic or periampullary cancer.
  • Prior radiation to any area within the planned radiation field. All patients with history of prior radiation to any area must be approved by PI.
  • Evidence of distant metastases on imaging.
  • History of hypersensitivity to fluoropyrimidines or HDACs.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

Other trials in United States

About this study

Official title: Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer.

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving capecitabine and vorinostat together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with capecitabine and radiation therapy in treating patients with nonmetastatic pancreatic cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of vorinostat when given in combination with capecitabine and high-dose hypofractionated radiotherapy in patients with nonmetastatic pancreatic cancer.

Secondary

  • Determine the safety and side effect profile of this regimen in these patients.
  • Determine the response rate in patients treated with this regimen.

Correlative

  • Compare pre- and post-treatment whole-cell HDAC-activity levels in peripheral blood mononuclear cell samples.
  • Assess chromatin structure and DNA damage in surgical tumor tissue samples.
  • Assess proliferation and apoptosis by in vivo imaging.

OUTLINE: This is a dose-escalation study of vorinostat.

Patients receive oral capecitabine twice daily and undergo high-dose hypofractionated radiotherapy once daily on days 1-5 and 8-12. Patients also receive oral vorinostat once daily on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity.

Patients are evaluated for surgery within 6 weeks after completion of chemoradiotherapy. Patients with resectable disease proceed to surgery. Patients with unresectable disease may receive oral vorinostat once daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for correlative laboratory studies. Patients also undergo diffusion-weighted MRI for analysis of in vivo tumor cellularity.

After completion of study therapy, patients are followed up periodically for 5 years.

Being tested
capecitabine, vorinostat, Radiotherapy, Surgery to remove tumor
Keywords
periampullary adenocarcinoma, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • capecitabineDrug

    1000 mg taken by mouth on the days of radiation only.

  • vorinostatDrug

    Vorinostat will be given by mouth on the day of radiation and then Monday-Friday for two weeks after radiation in these 4 possible doses:

    • Vorinostat,at 100 mg
    • Vorinostat,at 200 mg
    • Vorinostat, at 300 mg
    • Vorinostat, at 400 mg

  • RadiotherapyRadiation

    High-dose hypofractionated radiotherapy consisting of 3000 cGy in 10 fractions, Monday-Friday for 2 weeks.

  • Surgery to remove tumorProcedure or surgery

    Patients will be assessed for resectability within six weeks of the end of chemoradiation, if resectable, surgery will be performed.

Study groups in NCT00983268
Study groupRoleWhat they receive
Treatment ArmExperimentalNot described
Receives: Drug: capecitabine; Drug: vorinostat; Radiation: Radiotherapy; Procedure: Surgery to remove tumor

What is being measured

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

  1. Maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy

    Measured: Two weeks after completing radiotherapy

Secondary outcomes (3)

  1. Toxicity as assessed by NCI CTCAE v3.0

    Measured: Six weeks after completing chemo-radiation therpay

  2. Tumor response as assessed by RECIST criteria

    Measured: Six weeks after completing chemo-radiation therpay

  3. Biological effect

    Measured: Six weeks after completing chemo-radiation therapy

Timeline

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

  1. First posted24 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00983268
Sponsor's protocol ID
VICC GI 0934
Other IDs
P30CA068485, VU-VICC-GI-0934, IRB# 090791, NCCN-M02
Status last verified
Jun 2015
First submitted
23 Sep 2009
Last updated
15 Jun 2015
Results posted
No
Data monitoring committee
Yes

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 study testing capecitabine, vorinostat and Radiotherapy in people with Pancreatic Cancer and Periampullary Adenocarcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site 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 22 inclusion and 4 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 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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?

Maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy (time frame: Two weeks after completing radiotherapy). 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 NCT00983268, 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 15 Jun 2015.

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Clinical Trial NCT00983268 | AzTrials