Trial Outcomes & Findings for Sunitinib and Capecitabine for First Line Colon Cancer (NCT NCT00961571)
NCT ID: NCT00961571
Last Updated: 2025-02-12
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
36 months
Results posted on
2025-02-12
Participant Flow
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
Participant milestones
| Measure |
Sunitinib and Cepecitabine
Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Sunitinib and Cepecitabine
Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
|
|---|---|
|
Overall Study
Physician Decision
|
39
|
Baseline Characteristics
Sunitinib and Capecitabine for First Line Colon Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib and Cepecitabine
n=11 Participants
Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Sunitinib and Cepecitabine
n=11 Participants
Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
|
|---|---|
|
Progression-free Survival
|
18.35 months
Interval 7.57 to 31.57
|
Adverse Events
Sunitinib and Cepecitabine
Serious events: 8 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sunitinib and Cepecitabine
n=11 participants at risk
Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
|
|---|---|
|
Hepatobiliary disorders
Hypoalbuminemia
|
45.5%
5/11
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
9.1%
1/11
|
|
General disorders
Fatigue
|
9.1%
1/11
|
|
General disorders
Febrile neutropenia
|
9.1%
1/11
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
1/11
|
|
General disorders
Nausea
|
9.1%
1/11
|
|
Nervous system disorders
Neuropathy
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
27.3%
3/11
|
|
Gastrointestinal disorders
GI Obstruction
|
18.2%
2/11
|
Other adverse events
| Measure |
Sunitinib and Cepecitabine
n=11 participants at risk
Administration of sunitinib and capecitabine
sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
|
|---|---|
|
Gastrointestinal disorders
Alkaline phosphatase
|
27.3%
3/11
|
|
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
18.2%
2/11
|
|
Gastrointestinal disorders
Anorexia
|
36.4%
4/11
|
|
Hepatobiliary disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
36.4%
4/11
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
9.1%
1/11
|
|
General disorders
Bruising
|
9.1%
1/11
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11
|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11
|
|
General disorders
Dehydration
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
9.1%
1/11
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11
|
|
General disorders
Dry Lips
|
9.1%
1/11
|
|
General disorders
Dysphagia (difficulty swallowing)
|
9.1%
1/11
|
|
General disorders
Edema: limb
|
9.1%
1/11
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
45.5%
5/11
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
9.1%
1/11
|
|
Endocrine disorders
Hyperglycemia
|
18.2%
2/11
|
|
General disorders
Hematoma
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Hemoglobin
|
54.5%
6/11
|
|
Blood and lymphatic system disorders
Hemorrhage, CNS
|
9.1%
1/11
|
|
Gastrointestinal disorders
Hemorrhage, GI::Abdomen
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Hemorrhage, GU::Urinary
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other
|
9.1%
1/11
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
90.9%
10/11
|
|
Blood and lymphatic system disorders
Lymphopenia
|
27.3%
3/11
|
|
Blood and lymphatic system disorders
Hypermagnesemia
|
9.1%
1/11
|
|
General disorders
Mucositis/stomatitis
|
18.2%
2/11
|
|
General disorders
Nausea
|
45.5%
5/11
|
|
Nervous system disorders
Neurology - Other
|
9.1%
1/11
|
|
Nervous system disorders
Neuropathy: sensory
|
27.3%
3/11
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
63.6%
7/11
|
|
General disorders
Pain - Other
|
18.2%
2/11
|
|
General disorders
Pain::Abdomen
|
27.3%
3/11
|
|
General disorders
Pain::Back
|
9.1%
1/11
|
|
Renal and urinary disorders
Pain::Urethra
|
9.1%
1/11
|
|
Blood and lymphatic system disorders
Platelets
|
36.4%
4/11
|
|
Blood and lymphatic system disorders
Hypokalemia
|
9.1%
1/11
|
|
General disorders
Rash/desquamation
|
9.1%
1/11
|
|
General disorders
Sweating (diaphoresis)
|
9.1%
1/11
|
|
General disorders
Taste alteration (dysgeusia)
|
18.2%
2/11
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
9.1%
1/11
|
|
General disorders
Tremor
|
9.1%
1/11
|
|
General disorders
Weight loss
|
27.3%
3/11
|
Additional Information
Dr. Aiwu Ruth He
Georgetown University, Department of Medicine and Oncology
Phone: 202-444-8642
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60