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Pancreatic CancerPhase 1NCT01025882

Margin-Intense Combo Therapy in Pts w/Potentially Resectable Pancreatic Cancer

A Phase 1 study testing gemcitabine hydrochloride and stereotactic body radiation therapy in people with Pancreatic Cancer, run by University of Texas Southwestern Medical Center 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

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
gemcitabine hydrochloride and stereotactic body radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Oct 2009to 18 Feb 2011
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Pathologically confirmed localized adenocarcinoma of the pancreas or distal common bile duct
  • Pancreatic ductal adenocarcinoma or peripancreatic cholangiocarcinoma
  • Resectable disease, as determined by the Gastrointestinal Cancer Working Group disease-oriented team
  • Criteria used to define unresectability will include, but not be limited to, the following:
  • Tumor encases > 180 degrees of the circumference of the superior mesenteric artery
  • Tumor encases the common hepatic artery with no anatomic option for reconstruction following segmental resection
  • Superior mesenteric vein occluded or encased with no option for reconstruction following segmental resection
  • Soft tissue infiltration of the retroperitoneum to the left of the superior mesenteric artery
  • All malignant disease must be encompassed within a single radiotherapy field
  • No metastatic disease

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute granulocyte count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Creatinine clearance > 50mL/min
  • AST and ALT < 5 times upper limit of normal
  • Serum bilirubin < 5 mg/dL (with biliary decompression)
  • INR ≤ 1.5
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Medically fit for pancreatic surgical resection, as determined by the investigating surgeons at the time of study enrollment
  • No evidence of an active second invasive malignancy outside the area of the pancreas or biliary system within the past 2 years, except for non-melanomatous skin cancer or carcinoma in situ of the breast, bladder, cervix, or uterus
  • No clinically significant cardiac disease, including the following:
  • Uncontrolled hypertension, defined as blood pressure > 160/90 mm Hg on medication
  • Myocardial infarction within the past 6 months
  • NYHA class II-IV congestive heart failure
  • Unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [atrial fibrillation or paroxysmal supraventricular tachycardia])
  • Atrial arrhythmia allowed provided it is well-controlled on stable medication
  • No current or recent (within the past 6 months) unstable angina
  • No recent (within the past 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, or clinically significant peripheral artery disease
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days
  • No serious nonhealing wound, ulcer, or currently healing fracture
  • No AIDS
  • No significant infection or other coexisting medical condition that would preclude study therapy
  • No gastrointestinal fistula or perforation within the past 10 years

PRIOR CONCURRENT THERAPY:

  • More than 2 years since prior chemotherapy (other than for pancreaticobiliary cancer)
  • More than 28 days since prior major surgical procedure or open biopsy
  • No prior intraabdominal radiotherapy in the planned field of pancreatic margin-intensive radiotherapy
  • No prior organ transplantation
  • No concurrent major surgical procedure
  • No other concurrent cytotoxic chemotherapy or anti-neoplastic biologic agents

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic body radiation therapy together with gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of stereotactic body radiation therapy when given with or without gemcitabine hydrochloride in treating patients with pancreatic cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

  • To demonstrate the feasibility and safety of administering margin-intensive stereotactic body radiotherapy together with preoperative gemcitabine hydrochloride to patients with resectable pancreatic adenocarcinoma.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine hydrochloride. Patients receive 1 of 2 treatment regimens.

  • Regimen 1: Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
  • Regimen 2: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.

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

Keywords
adenocarcinoma of the pancreas, 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.

Study groups in NCT01025882
Study groupRoleWhat they receive
Regimen 1ExperimentalPatients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
Receives: Radiation: stereotactic body radiation therapy
Regimen 2ExperimentalPatients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.
Receives: Drug: gemcitabine hydrochloride; Radiation: stereotactic body radiation therapy

What is being measured

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

  1. Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection

  2. Postoperative surgical morbidity, defined as all other adverse events occurring within 90 days of surgery

  3. Total dose of chemotherapy and radiotherapy delivered

  4. Pre-treatment and post-treatment characteristics of the primary tumor on preoperative axial imaging including, but not limited to, tumor size, percentage of encasement/abutment of mesenteric vessels, and progression of disease

  5. Postoperative complications including, but not limited to, need for reoperation, need for interventional radiology fluid collection drainage, systemic infection, wound infection, prolonged ICU stay, and delayed gastric emptying

  6. Operative drain amylase at days 3 and 5 postoperatively

  7. Length of hospital stay following pancreatic resection

  8. Degree of histologic response of tumor in the resected specimen

  9. Tumor samples for RNA and protein harvesting (when possible) from pretreatment biopsies and surgical specimens

Timeline

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

  1. First posted4 Dec 2009 (estimated)
  2. Study startOct 2009
  3. Primary completion18 Feb 2011
  4. Study completion18 Feb 2011

Why it stopped: DSMC closed due to patient deaths

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01025882
Sponsor's protocol ID
SCCC-01209
Other IDs
CDR0000657523, NCI-2011-01117
Status last verified
Feb 2019
First submitted
3 Dec 2009
Last updated
5 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing gemcitabine hydrochloride and stereotactic body radiation therapy in people with Pancreatic Cancer, run by University of Texas Southwestern Medical 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?

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 5 Feb 2019. 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 was stopped early (reason given: DSMC closed due to patient deaths). Results are not available in the source record.

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?

Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection. The study lists 9 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 NCT01025882.

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 5 Feb 2019.

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