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AzTrials

Pancreatic CancerPhase 2NCT01754623

GTX-RT in Borderline Resectable Pancreatic Cancer

A Phase 2 study testing Capecitabine, Gemcitabine and Docetaxel in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site 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 purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed… 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?
Capecitabine, Gemcitabine and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Feb 2013to Oct 2014
Phase
Phase 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

  • Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as:
  • circumferential tumor abutment with the superior mesenteric vein (SMV) or portal vein (PV) or SMV/PV confluence over </= 180°
  • circumferential tumor abutment with the superior mesenteric artery (SMA) over </= 180°
  • Short segment encasement (360°) of the PV or SMV that is amenable to partial vein resection and reconstruction
  • encasement of the gastroduodenal artery up to the origin of the hepatic artery
  • Patients must have measurable disease
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  • No previous chemotherapy or radiation to the pancreas
  • Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%)
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes >/= 3,000/μL
  • absolute neutrophil count >/= 1,000/ μL
  • platelets >/= 100,000/ μL
  • creatinine within normal institutional limits (ULN)
  • total bilirubin will allow for 2x the upper limit of the institution. Patients may have biliary stents or drains to lower total bilirubin to this range.
  • Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential). Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients with metastatic disease are ineligible.
  • Patients who have had prior chemotherapy for pancreatic adenocarcinoma
  • Patients who have received prior radiation to an abdominal site are not eligible.
  • Patients with peripheral neuropathy >/= grade 2
  • Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel), other drugs formulated with polysorbate 80, gemcitabine, or capecitabine
  • Patients may not be receiving any other investigational agents.
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  • ECOG Performance Status 3-4
  • Pregnant or breast-feeding women are excluded from this study because gemcitabine,capecitabine, and docetaxel are Class D agents with the potential for teratogenic or abortifacient effects.
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Validation of a Radiation Response Signature in Borderline Resectable Pancreatic Cancer Patients Treated With Induction Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT)

The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed completely.

Read the detailed description

Investigators plan to conduct a prospective pilot phase II trial of GTX-SBRT as neoadjuvant treatment of borderline resectable pancreatic cancer. After informed consent, pretreatment pancreatic tumor tissues will be collected and immediately frozen at the time of staging endoscopic ultrasound (EUS). Ribonucleic acid (RNA) will be extracted from tumor specimens and run on microarray analysis to determine radiosensitivity index score. Borderline resectable (BR) patients will be treated with 3 cycles of GTX chemotherapy followed by SBRT. They will be restaged and evaluated for resectability 3 to 4 weeks later. Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery.

Being tested
Capecitabine, Gemcitabine, Docetaxel, Stereotactic body radiation therapy (SBRT), Restaging review after radiation
Keywords
Pancreas, Pancreatic, Neoplasms, Stereotactic, Radiosurgery, Borderline, Resectable, Gastrointestinal, Gemcitabine, Capecitabine, Fluorouracil, Docetaxel, SBRT, GTX Chemotherapy
Medical subject headings
Pancreatic Neoplasms, Neoplasms

What participants receive

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

  • CapecitabineDrug

    Also called Xeloda®

    Treatment will begin with the first round of chemotherapy. Each round of chemotherapy will take 21 days. Each round or cycle will start with participants taking capecitabine pills. Participants will take tablets of capecitabine (Xeloda®) twice per day for 14 days followed by 7 days without capecitabine.

  • GemcitabineDrug

    Also called Gemzar®

    On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. First, this will consist of placing gemcitabine (Gemzar®) in a bag of fluid and giving it by vein over 30 minutes.

  • DocetaxelDrug

    Also called Taxotere®

    On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. After the gemcitabine, participants will receive docetaxel (Taxotere®) in a bag of fluid over 1 hour.

  • Stereotactic body radiation therapy (SBRT)Radiation

    Also called SBRT

    30/40 Gy to pancreatic tumor/area of borderline resectability

  • Restaging review after radiationOther

    After radiation, participants will be re-evaluated for surgery. Patients who have Complete Response (CR), Partial Response (PR) or stable disease (SD) will proceed with surgical exploration and resection provided they are suitable fit for surgery in the judgment of the surgical oncologist. Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT). If no surgery: then chemotherapy. If surgery: chemotherapy will be given based on response.

  • SurgeryProcedure or surgery

    Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery. After surgery, chemotherapy will be given based on response.

  • 5-FluorouracilDrug

    Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT).

Study groups in NCT01754623
Study groupRoleWhat they receive
Chemotherapy Followed by Radiation TreatmentExperimentalGemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
Receives: Drug: Capecitabine; Drug: Gemcitabine; Drug: Docetaxel; Radiation: Stereotactic body radiation therapy (SBRT); Other: Restaging review after radiation; Procedure: Surgery; Drug: 5-Fluorouracil

What is being measured

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

  1. Margin-negative (R0) Resection Rate

    R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.

    Measured: Up to 3 years

Secondary outcomes (2)

  1. Progression-Free Survival (PFS) at Three Years

    PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.

    Measured: 3 years

  2. Overall Survival (OS) Rate

    OS at time of analysis, calculated from date of enrollment to date of death from any cause.

    Measured: 12 months

Timeline

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

  1. First posted21 Dec 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionSep 2014
  4. Study completionOct 2014

Why it stopped: Lack of pre-treatment tissue to make the study plan feasible.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01754623
Sponsor's protocol ID
MCC-16932
Status last verified
Jun 2015
First submitted
18 Dec 2012
Last updated
13 Aug 2015
Data monitoring committee
No

Publications

  • Strom T, Hoffe SE, Fulp W, Frakes J, Coppola D, Springett GM, Malafa MP, Harris CL, Eschrich SA, Torres-Roca JF, Shridhar R. Radiosensitivity index predicts for survival with adjuvant radiation in resectable pancreatic cancer. Radiother Oncol. 2015 Oct;117(1):159-64. doi: 10.1016/j.radonc.2015.07.018. Epub 2015 Jul 30.

    PubMed 26235848

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Gemcitabine and Docetaxel in people with Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 16 inclusion and 10 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 13 Aug 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 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 13 Aug 2015). 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?

Margin-negative (R0) Resection Rate (time frame: Up to 3 years). 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 NCT01754623, 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 13 Aug 2015.

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