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Pancreatic CancerPhase 2PMABIISNCT01130701

A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . .

A Phase 2 study testing Neoadjuvant capecitabine, panitumumab and radiation in people with Pancreatic Cancer, run by University of Massachusetts, Worcester at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out whether this combination is effective and safe to use before surgery. 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?
Neoadjuvant capecitabine, panitumumab and radiation
Type of treatment
Pill or oral medicine
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2010to Dec 2015
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

  • Cytological or histological confirmation of pancreatic adenocarcinoma is required.
  • Only patients with localized and apparently resectable, non-metastatic tumors are eligible. All patients must be staged with a chest X-ray or chest CT and abdominal and pelvic CT scan or MRI.
  • One of the following radiological criteria must be met and recorded in chart by dedicated surgeon prior to enrollment.
  • A)Localized, potentially resectable : 1) no evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery; 2) no evidence of tumor encasement or occlusion of superior mesenteric vein (SMV) or the SMV/portal vein(PV) confluence; 3) no evidence of visceral or peritoneal metastasis
  • B)Borderline resectable: 1) no extra pancreatic disease, (2) the following possible tumor-vessel relationships: an SMV-PV confluence that can be reconstructed even if short segment venous occlusion is present; tumor abutment of the SMA of ≤180°; or short segment encasement of the hepatic artery amenable to resection and reconstruction.
  • Patients with the following radiological criteria are NOT eligible:
Show all 13Show fewer
  • Locally advanced disease: (1) no extra pancreatic disease, (2) tumor encasement of the SMA or celiac axis defined as tumor involvement of >180° of the arterial circumference. B) Radiographic evidence of distant organ or peritoneal metastases.
  • Age > 18 years.
  • ECOG performance status 0 and 1.
  • Patient must have adequate hematological, renal and hepatic function defined as:
  • WBC > 2,000 cells/mm3 ANC>1500 cells/mm3 Hemoglobin > 9.0 g/dL Platelets > 100,000 cells/mm3 Serum creatinine < 1.5 x upper limit of normal (UNL) or a calculated creatinine clearance of > 50 mL/min calculated by Cockcroft-Gault method Total bilirubin < 2.5 mg/dl AST < 3x upper limits of normal ALT < 3x upper limits of normal
  • Serum calcium and magnesium levels within limits of normal
  • Patients may not have any prior therapy for carcinoma of the pancreas, nor prior abdominal radiation therapy.

Who cannot join

  • Patients with any other malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Psychiatric illness which would prevent the patient from giving informed consent.
  • Serious medical illness which would limit anticipated survival to < 12 weeks.
  • Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for six months after the trial. Non-pregnant and non-breast-feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic > 12 months to be considered not of childbearing potential. All patients (men and women) of reproductive potential must agree to use an effective method of birth-control while receiving study therapy and for six months after completion of therapy.
  • Inability to swallow medication. Patients should have adequate, unassisted oral intake.
  • Inability to hold still and cooperate during radiotherapy.
  • Prior history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase II Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, Panitumumab and External Beam Radiation, in Patients With Localized, Non-Metastatic Pancreatic Adenocarcinoma

In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out whether this combination is effective and safe to use before surgery.

Read the detailed description

Surgical resection remains the standard procedure for patients with localized resectable pancreatic cancer.

Neoadjuvant or preoperative therapy with chemotherapy and radiation therapy has been proposed as an alternative approach in patients with localized pancreatic adenocarcinoma.

Advantages are: 1) early start of systemic therapy targeting micrometastatic disease; 2) increased compliance with chemoradiotherapy; 3) increase primary tumor complete resection rates; 4) avoidance of surgery in patients with rapidly developing metastatic disease; and 5) importantly, it provides an important resource for research in terms of tissue acquisition before and after therapy . Finally, this is an opportunity to test the safety and efficacy of a novel combination of weekly panitumumab, oral capecitabine and radiation in pancreatic cancer.

Being tested
Neoadjuvant capecitabine, panitumumab and radiation
Keywords
Pancreatic Cancer, Neoadjuvant, Panitumumab, Capecitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Neoadjuvant capecitabine, panitumumab and radiationOther

    Also called Xeloda, Vectibix; NSC # 742319

    Patients will receive six weekly doses of panitumumab (2.5mg/kg) in conjunction oral capecitabine 825 mg/m2 PO bid Mon-Friday and external beam radiation therapy. Panitumumab and oral capecitabine will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy.

    Patients will be reevaluated for surgical resection 4-6 weeks after completion of neoadjuvant therapy.

    After surgical resection, adjuvant systemic chemotherapy with gemcitabine for six months is strongly recommended for all patients.

What is being measured

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

  1. To estimate the 3 year progression-free survival of patients with localized, resectable pancreatic cancer

    To estimate the proportions of patients (with localized, resectable and borderline resectable, non-metastatic pancreatic adenocarcinoma) treated with the study regimen alive at 2-years from the date of registration.

    Measured: 2 Years

Secondary outcomes (1)

  1. To estimate resection rate

    To determine the fraction of patients that proceed to planned surgery with the removal of primary tumor (R0/R1) following neoadjuvant therapy; estimate the overall survival in this patient population; evaluate the rate of R0, R1 and R2 resection (defined as per 6th edition of AJCC Cancer Staging Manual) in patients treated with neoadjuvant therapy; the overall response rate to chemoradiation therapy; the biomarker response to chemoradiation through evaluation of circulating CA19-9 levels; to evaluate the toxicity associated with this regimen.

    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 posted26 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Why it stopped: Study never went beyond FDA application for an IND #. FDAA required institutional DSMC which this institution then lacked.

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
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130701
Sponsor's protocol ID
UM2010-01
Acronym
PMABIIS
Status last verified
Aug 2011
First submitted
24 May 2010
Last updated
17 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Willett CG, Czito BG. Does adjuvant chemoradiation benefit patients who have undergone resection of pancreatic or periampullary cancer? Nat Clin Pract Gastroenterol Hepatol. 2008 Jul;5(7):364-5. doi: 10.1038/ncpgasthep1152. Epub 2008 May 27. No abstract available.

    PubMed 18506163

  • Meyer JJ, Willett CG, Czito BG. Is there a role for advanced radiation therapy technologies in the treatment of pancreatic adenocarcinoma? Future Oncol. 2008 Apr;4(2):241-55. doi: 10.2217/14796694.4.2.241.

    PubMed 18407737

  • Geer RJ, Brennan MF. Prognostic indicators for survival after resection of pancreatic adenocarcinoma. Am J Surg. 1993 Jan;165(1):68-72; discussion 72-3. doi: 10.1016/s0002-9610(05)80406-4.

    PubMed 8380315

  • Snady H, Bruckner H, Cooperman A, Paradiso J, Kiefer L. Survival advantage of combined chemoradiotherapy compared with resection as the initial treatment of patients with regional pancreatic carcinoma. An outcomes trial. Cancer. 2000 Jul 15;89(2):314-27. doi: 10.1002/1097-0142(20000715)89:23.0.co;2-v.

    PubMed 10918161

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant capecitabine, panitumumab and radiation in people with Pancreatic Cancer, run by University of Massachusetts, Worcester 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 13 inclusion and 7 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: withdrawn, as of the sponsor's last update on 17 Mar 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

To estimate the 3 year progression-free survival of patients with localized, resectable pancreatic cancer (time frame: 2 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 NCT01130701, which also lists 4 linked publications.

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 17 Mar 2015; AzTrials last refreshed its copy on 31 Oct 2026.

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