Trial · NCT01093222

Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma

NCT01093222, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-01-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma. Trials, record NCT01093222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01093222

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma
NCT number: NCT01093222
Status: Completed
Phases: Phase 2
Enrollment: 40 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Extrahepatic Bile Duct Adenocarcinoma, Gallbladder Adenocarcinoma, Gallbladder Adenocarcinoma With Squamous Metaplasia, Hilar Cholangiocarcinoma, Recurrent Extrahepatic Bile Duct Carcinoma, Recurrent Gallbladder Carcinoma, Undifferentiated Gallbladder Carcinoma, Unresectable Extrahepatic Bile Duct Carcinoma, Unresectable Gallbladder Carcinoma
Interventions: Erlotinib Hydrochloride, Sorafenib Tosylate
First posted: 2010-03-25
Last updated: 2015-06-30
Results first posted: 2014-01-29
Limitations and caveats: The first stage of accrual was met with 40 registered patients. Insufficient number of patients were alive and free from progression at four months to warrant accruing to a second stage.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival	Up to 3 years	From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Secondary	Overall Survival	Up to 3 years	From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Secondary	Objective Response	Up to 3 years	Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Secondary	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Up to 3 years	Only adverse events that are possibly, probably or definitely related to study drug are reported.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Overall Survival	Up to 3 years	Eligible patients who began protocol therapy	months	MEDIAN
PRIMARY	Progression-free Survival	Up to 3 years	Eligible patients who began protocol therapy	months	MEDIAN
SECONDARY	Objective Response	Up to 3 years	Eligible patients who began protocol therapy	percentage of participants	NUMBER
SECONDARY	Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Up to 3 years	Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	Sorafenib and Erlotinib		6	95% Confidence Interval 3 to 8	months
Progression-free Survival	Sorafenib and Erlotinib		2	95% Confidence Interval 2 to 3	months
Objective Response	Sorafenib and Erlotinib		6	95% Confidence Interval 1 to 20	percentage of participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Sorafenib and Erlotinib	Abdominal pain	1		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Sorafenib and Erlotinib	Alanine aminotransferase increased	4		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Sorafenib and Erlotinib	Alkaline phosphatase increased	3		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Sorafenib and Erlotinib	Allergic reaction	1		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Sorafenib and Erlotinib	Aspartate aminotransferase increased	3		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Sorafenib and Erlotinib	Blood bilirubin increased	2		Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Sorafenib and Erlotinib	Death NOS	1		Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sorafenib and Erlotinib	40
Overall Study	Eligible and Began Protocol Therapy	Sorafenib and Erlotinib	34
Overall Study	COMPLETED	Sorafenib and Erlotinib	0
Overall Study	NOT COMPLETED	Sorafenib and Erlotinib	40

Source ClinicalTrials.gov

Adverse events106

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Sorafenib and Erlotinib	11	34
other	Leukocytosis	Blood and lymphatic system disorders	Sorafenib and Erlotinib	2	34
other	Conjunctivitis	Eye disorders	Sorafenib and Erlotinib	2	34
other	Dry eye	Eye disorders	Sorafenib and Erlotinib	2	34
other	Abdominal distension	Gastrointestinal disorders	Sorafenib and Erlotinib	3	34
other	Abdominal pain	Gastrointestinal disorders	Sorafenib and Erlotinib	13	34
other	Constipation	Gastrointestinal disorders	Sorafenib and Erlotinib	15	34
other	Diarrhea	Gastrointestinal disorders	Sorafenib and Erlotinib	20	34
other	Dry mouth	Gastrointestinal disorders	Sorafenib and Erlotinib	4	34
other	Dyspepsia	Gastrointestinal disorders	Sorafenib and Erlotinib	6	34

1 to 10 of 106Source ClinicalTrials.gov

See all 106 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sorafenib and Erlotinib
Total, other adverse events	Sorafenib and Erlotinib	33	34
Total, serious adverse events	Sorafenib and Erlotinib	17	34

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01093222

GET https://conductscience.org/api/trials/v1/NCT01093222/results?page=2

API reference For AI assistants