CClinicalTrials.gg
Sign In
CompletedNCT00948935Updated Mar 11, 2020Results posted

Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

A Phase 2 interventional study of Gemcitabine, Irinotecan, Panitumumab in Biliary Cancer and Cholangiocarcinoma, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-11.

Sponsored by Abramson Cancer Center at Penn Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Biliary Cancer
  • Cholangiocarcinoma

Keywords

  • Biliary Cancer
  • Cholangiocarcinoma
  • Panitumumab
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 35 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Chemotherapy

    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

  • DrugGemcitabine, Irinotecan, Panitumumab

    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.

06

What researchers measure

Primary outcomes

  1. Progression Free Survival Rate at Five Months

    Time frame: 5 months

Secondary outcomes

  1. Response Rate From Combination Chemotherapy

    Time frame: 5 months

07

Results

Posted Jun 18, 2019

Participant flow

Participant flow — Overall Study
MilestoneChemotherapy
Started35
Completed35
Not completed0

Outcome measures

PrimaryProgression Free Survival Rate at Five Months
Time frame:
5 months
Reported as:
Number · percentage of participants
Progression Free Survival Rate at Five Months
percentage of participantsChemotherapy
Progression Free Survival Rate at Five Months69
SecondaryResponse Rate From Combination Chemotherapy
Time frame:
5 months
Reported as:
Count of participants · Participants
Response Rate From Combination Chemotherapy
ParticipantsChemotherapy
Complete Response2
Partial Response9
Stable Disease15
Progressive Disease2
Not Assessable7

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chemotherapy—21/35 (60%)35/35 (100%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventChemotherapy
DehydrationGastrointestinal disorders5/35
FeverGeneral disorders4/35
Thrombosis/thombus/embolismVascular disorders4/35
Obstruction, GIGastrointestinal disorders3/35
DiarrheaGastrointestinal disorders2/35
Cardiac ArrhythmiaCardiac disorders1/35
FatigueGeneral disorders1/35
Respiratory ArrestRespiratory, thoracic and mediastinal disorders1/35
RashSkin and subcutaneous tissue disorders1/35
Free AirGastrointestinal disorders1/35
Most frequent other events
Showing 10 of 189
Most frequent other events
EventChemotherapy
rashSkin and subcutaneous tissue disorders33/35
anemiaBlood and lymphatic system disorders32/35
HypoalbuminemiaMetabolism and nutrition disorders28/35
low calciumMetabolism and nutrition disorders28/35
hypergylcemiaMetabolism and nutrition disorders27/35
fatigueGeneral disorders26/35
diarrheaGastrointestinal disorders25/35
nauseaGastrointestinal disorders25/35
Platelet count decreasedInvestigations25/35
Aspartate Aminotransferase (high)Metabolism and nutrition disorders24/35

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Chemotherapy
<=18 years0
Between 18 and 65 years20
>=65 years15
Age, Continuous
Age, Continuous(years)Chemotherapy
Median62 (26 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)Chemotherapy
Female17
Male18
Region of Enrollment
Region of Enrollment(participants)Chemotherapy
United States35
08

Study locations

1 site
  • Abramson Cancer Center at University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Publications

  • 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. PubMed 24146220 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00948935
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Jul 29, 2009
Start date
Apr 2009
Primary completion
Sep 2014
Completion
Sep 26, 2014
Results posted
Jun 18, 2019
Last update
Mar 11, 2020

Study contacts

Bruce Giantonia, MD
principal investigator · Abramson CC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Adenocarcinoma→

Other studies from this sponsor

Abramson Cancer Center at Penn Medicine

Start the discussion