NCT01434459

Brief Summary

Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer. The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 4, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

September 12, 2011

Last Update Submit

May 1, 2015

Conditions

Pancreatic NeoplasmsCholangiocarcinoma

Keywords

Pancreatic neoplasmsCholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • The maximum tolerated dose of gemcitabine when given in combination with therasphere

    Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.

    28 days

Secondary Outcomes (3)

  • Toxicities (side effects) experienced by patients on the trial

    90 days

  • Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan .

    78 days

  • The progression free of patients treated on the trial

    12 months

Study Arms (1)

Gemcitabine with TheraSphere

EXPERIMENTAL
Drug: Gemcitabine with TheraSphere

Interventions

Gemcitabine with TheraSphereDRUG

Gemcitabine dose will be escalated and combined with therasphere.

Also known as: TheraSphere_radioembolization, Gemcitabine- Gemzar
Gemcitabine with TheraSphere

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma
  • Liver predominant disease defined as
  • \- Cholangiocarcinoma: liver disease should be unresectable
  • \- Limited extra hepatic metastasis defined as: i. Lung metastasis: 6 or less nodules with no nodule greater than 1.5 cm.
  • ii. Abdominal lymph nodes iii. Pancreatic primary as long as the size is less than 4 cm in size iv. Bone metastasis
  • No prior systemic therapy for advanced stage disease
  • Measurable target tumors using standard imaging techniques
  • Lung shunting less than 20%
  • ECOG performance status 0-1 (See Appendix )
  • Age ≥ 18 years
  • No other investigational agents while on protocol
  • Signed informed consent

You may not qualify if:

  • Inadequate hepatic function: AST/ALT \> five times upper limit of normal, Bilirubin \>2.0 mg/dl or history of hepatic encephalopathy
  • Inadequate renal function Creatinine \> 2.0 mg/dL
  • Inadequate bone marrow function: platelets \< 100,000/mL or absolute neutrophil count \<1500/mL
  • Contraindication to angiography
  • Prior external beam radiotherapy to the upper abdomen
  • Clinical evidence of peritoneal metastasis or ascites
  • Patients with extensive tumor replacement in the liver defined as \>50% of liver involved with tumor
  • Any serious ongoing extra-hepatic disease such as infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsCholangiocarcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Hyun Kevin Kim, MD

    Emory University Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Bassel El-Rayes, MD

    Emory University Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2011

First Posted

September 15, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2014

Study Completion

September 1, 2014

Last Updated

May 4, 2015

Record last verified: 2015-05

Locations

US(1)