Sunitinib and Capecitabine for First Line Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00961571

Recruitment Status : Terminated (Unanticipated side effects and futility)

First Posted : August 19, 2009

Results First Posted : April 21, 2017

Last Update Posted : April 3, 2018

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Ruth He, Georgetown University

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Metastatic Colorectal Cancer
Intervention	Drug: sunitinib and capecitabine
Enrollment	50

Participant Flow

Recruitment Details	From 2007 to 2008, we treated patients with unresectable advanced colorectal cancer with Sunitnib 37.5 mg orally once daily and Capecitabine 1000 mg orally twice daily in a phase II clinical trial at Georgetown University Hospital
Pre-assignment Details


Arm/Group Title	Sunitinib and Cepecitabine
Arm/Group Description	Administration of sunitinib and cap...
Arm/Group Description	Administration of sunitinib and capecitabine sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
Period Title: Overall Study
Started	50
Completed	11 ^[1]
Not Completed	39
Reason Not Completed
Physician Decision	39
[1] high percentage of patient drop-off study prior cancer progression

Baseline Characteristics

Arm/Group Title		Sunitinib and Cepecitabine
Arm/Group Description		Administration of sunitinib and cap...
Arm/Group Description		Administration of sunitinib and capecitabine sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
Overall Number of Baseline Participants		11
Baseline Analysis Population Description		...
Baseline Analysis Population Description		metastatic colon cancer who has not received 1st line systemic chemotherapy
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	11 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	5 45.5%
	>=65 years	6 54.5%
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	11 participants
		67 (23 to 88)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	11 participants
	Female	5 45.5%
	Male	6 54.5%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	11 participants
United States		11

Outcome Measures

1.Primary Outcome


Title	Progression-free Survival
Description	Progression-free survival (PFS) will be measured as the number of mont...
Description	Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.


Arm/Group Title	Sunitinib and Cepecitabine
Arm/Group Description:	Administration of sunitinib and cap...
Arm/Group Description:	Administration of sunitinib and capecitabine sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
Overall Number of Participants Analyzed	11
Median (Full Range) Unit of Measure: months
	18.35 (7.57 to 31.57)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Sunitinib and Cepecitabine
Arm/Group Description	Administration of sunitinib and cap...
Arm/Group Description	Administration of sunitinib and capecitabine sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
All-Cause Mortality
	Sunitinib and Cepecitabine
	Affected / at Risk (%)
Total	1/11 (9.09%)
Serious Adverse Events Serious Adverse Events
	Sunitinib and Cepecitabine
	Affected / at Risk (%)
Total	8/11 (72.73%)
Blood and lymphatic system disorders
Lymphopenia ^†	1/11 (9.09%)
Neutrophils/granulocytes (ANC/AGC) ^†	3/11 (27.27%)
Gastrointestinal disorders
Gastrointestinal - Other ^†	1/11 (9.09%)
GI Obstruction ^†	2/11 (18.18%)
General disorders
Fatigue ^†	1/11 (9.09%)
Febrile neutropenia ^†	1/11 (9.09%)
Nausea ^†	1/11 (9.09%)
Hepatobiliary disorders
Hypoalbuminemia ^†	5/11 (45.45%)
Nervous system disorders
Neuropathy ^†	1/11 (9.09%)
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other ^†	1/11 (9.09%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Sunitinib and Cepecitabine
	Affected / at Risk (%)
Total	11/11 (100.00%)
Blood and lymphatic system disorders
Blood/Bone Marrow - Other ^†	1/11 (9.09%)
Hemoglobin ^†	6/11 (54.55%)
Hemorrhage, CNS ^†	1/11 (9.09%)
Hemorrhage, GU::Urinary ^†	1/11 (9.09%)
Hemorrhage/Bleeding - Other ^†	1/11 (9.09%)
Leukocytes (total WBC) ^†	10/11 (90.91%)
Lymphopenia ^†	3/11 (27.27%)
Hypermagnesemia ^†	1/11 (9.09%)
Neutrophils/granulocytes (ANC/AGC) ^†	7/11 (63.64%)
Platelets ^†	4/11 (36.36%)
Hypokalemia ^†	1/11 (9.09%)
Thrombotic microangiopathy ^†	1/11 (9.09%)
Endocrine disorders
Hyperglycemia ^†	2/11 (18.18%)
Gastrointestinal disorders
Alkaline phosphatase ^†	3/11 (27.27%)
Anorexia ^†	4/11 (36.36%)
Colitis ^†	1/11 (9.09%)
Constipation ^†	3/11 (27.27%)
Diarrhea ^†	3/11 (27.27%)
Gastrointestinal - Other ^†	1/11 (9.09%)
Hemorrhage, GI::Abdomen ^†	1/11 (9.09%)
General disorders
Bruising ^†	1/11 (9.09%)
Dehydration ^†	1/11 (9.09%)
Dry Lips ^†	1/11 (9.09%)
Dysphagia (difficulty swallowing) ^†	1/11 (9.09%)
Edema: limb ^†	1/11 (9.09%)
Fatigue (asthenia, lethargy, malaise) ^†	5/11 (45.45%)
Hematoma ^†	1/11 (9.09%)
Mucositis/stomatitis ^†	2/11 (18.18%)
Nausea ^†	5/11 (45.45%)
Pain - Other ^†	2/11 (18.18%)
Pain::Abdomen ^†	3/11 (27.27%)
Pain::Back ^†	1/11 (9.09%)
Rash/desquamation ^†	1/11 (9.09%)
Sweating (diaphoresis) ^†	1/11 (9.09%)
Taste alteration (dysgeusia) ^†	2/11 (18.18%)
Tremor ^†	1/11 (9.09%)
Weight loss ^†	3/11 (27.27%)
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase) ^†	2/11 (18.18%)
AST, SGOT(serum glutamic oxaloacetic transaminase) ^†	4/11 (36.36%)
Hepatobiliary/Pancreas - Other ^†	1/11 (9.09%)
Nervous system disorders
Neurology - Other ^†	1/11 (9.09%)
Neuropathy: sensory ^†	3/11 (27.27%)
Renal and urinary disorders
Pain::Urethra ^†	1/11 (9.09%)
Respiratory, thoracic and mediastinal disorders
Cough ^†	2/11 (18.18%)
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other ^†	1/11 (9.09%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Aiwu Ruth He
Organization:	Georgetown University, Department of Medicine and Oncology
Phone:	202-444-8642
EMail:	arh29@georgetown.edu

Layout table for additonal information

Responsible Party:	Ruth He, Georgetown University
ClinicalTrials.gov Identifier:	NCT00961571
Other Study ID Numbers:	GA61822D 2008-308 ( Other Identifier: IRB )
First Submitted:	August 18, 2009
First Posted:	August 19, 2009
Results First Submitted:	March 11, 2017
Results First Posted:	April 21, 2017
Last Update Posted:	April 3, 2018

To Top