NCT00948935

Brief Summary

This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2014

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

June 18, 2019

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

5.4 years

First QC Date

May 15, 2009

Results QC Date

April 16, 2019

Last Update Submit

March 9, 2020

Conditions

Biliary CancerCholangiocarcinoma

Keywords

Biliary CancerCholangiocarcinomaPanitumumab

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival Rate at Five Months

    5 months

Secondary Outcomes (1)

  • Response Rate From Combination Chemotherapy

    5 months

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Drug: Gemcitabine, Irinotecan, Panitumumab

Interventions

Gemcitabine, Irinotecan, PanitumumabDRUG

Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Chemotherapy

Eligibility Criteria

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

You may qualify if:

  • histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract
  • measurable disease
  • available tumor tissue for investigational immunohistochemical evaluations
  • ECOG PS 0-2
  • No prior chemotherapy, biologic therapy or radiation therapy
  • Age Eighteen and older
  • Lab values per protocol

You may not qualify if:

  • Life expectancy less than three months
  • Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment
  • Prior therapy, which affects or targets the EGF pathway
  • Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
  • Recovery from major surgery within three weeks of the start of study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Sohal DP, Mykulowycz K, Uehara T, Teitelbaum UR, Damjanov N, Giantonio BJ, Carberry M, Wissel P, Jacobs-Small M, O'Dwyer PJ, Sepulveda A, Sun W. A phase II trial of gemcitabine, irinotecan and panitumumab in advanced cholangiocarcinoma. Ann Oncol. 2013 Dec;24(12):3061-5. doi: 10.1093/annonc/mdt416. Epub 2013 Oct 20.

    PMID: 24146220DERIVED

MeSH Terms

Conditions

Biliary Tract NeoplasmsCholangiocarcinoma

Interventions

GemcitabineIrinotecanPanitumumab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCamptothecinAlkaloidsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Bruce Giantonio
Organization
Abramson Cancer Center
bruce.giantonio@uphs.upenn.edu
(215) 615-5858

Study Officials

  • Bruce Giantonia, MD

    Abramson CC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2009

First Posted

July 29, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 26, 2014

Last Updated

March 11, 2020

Results First Posted

June 18, 2019

Record last verified: 2020-03

Locations

US(1)