Trial Outcomes & Findings for Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer (NCT NCT00305643)

Last Updated: 2015-12-24

Results Overview

The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of \> grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

11 participants

Primary outcome timeframe

At 16 Weeks, with evaluations and blood test every 3 weeks.

Results posted on

2015-12-24

Participant Flow

Recruitment Period: February 27, 2006 to October 06, 2008 from various medical clinics and institutions representing the Community Clinical Oncology Program (CCOP).

Study terminated due to slow accrual.

Participant milestones

Participant milestones
Measure	Arm I: Celecoxib + Capecitabine Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).	Arm II: Placebo + Capecitabine Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I: Celecoxib + Capecitabine n=6 Participants Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).	Arm II: Placebo + Capecitabine n=5 Participants Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).	Total n=11 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	66 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Puerto Rico	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: At 16 Weeks, with evaluations and blood test every 3 weeks.

Population: No analysis could be performed due to low accrual and no participants reaching the 16 week mark.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 16 Weeks

Population: No analysis could be performed due to low accrual and no participants reaching the 16 week mark.

A secondary classification of palmar planter erythrodysethesia according to World Health Organization (WHO) criteria will be used for determination of the incidences of \> grade 1 HFS by 16 weeks from the commencement of therapy.

Outcome measures

Outcome data not reported

Adverse Events

Arm I: Celecoxib + Capecitabine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm II: Placebo + Capecitabine

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I: Celecoxib + Capecitabine n=6 participants at risk Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).	Arm II: Placebo + Capecitabine n=5 participants at risk Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).
Cardiac disorders Cardiac Ischemia	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months

Other adverse events

Additional Information

Scott Kopetz, MD, PHD / Assistant Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I: Celecoxib + Capecitabine n=6 participants at risk Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).	Arm II: Placebo + Capecitabine n=5 participants at risk Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day).
Skin and subcutaneous tissue disorders Acne	16.7% 1/6 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Metabolism and nutrition disorders Alkaline Phosphatase	16.7% 1/6 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	0.00% 0/5 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Musculoskeletal and connective tissue disorders Arthritis	16.7% 1/6 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	0.00% 0/5 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Blood and lymphatic system disorders Hemoglobin	33.3% 2/6 • Number of events 2 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	40.0% 2/5 • Number of events 2 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Blood and lymphatic system disorders Platelets	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Gastrointestinal disorders Gastrointestinal - Other	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
General disorders Fatigue	66.7% 4/6 • Number of events 4 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Skin and subcutaneous tissue disorders Hand-foot	16.7% 1/6 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	60.0% 3/5 • Number of events 3 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Gastrointestinal disorders Diarrhea	50.0% 3/6 • Number of events 3 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	0.00% 0/5 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	0.00% 0/5 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Blood and lymphatic system disorders Edema	16.7% 1/6 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	0.00% 0/5 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Gastrointestinal disorders Mucositis	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Vascular disorders Thrombosis	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Metabolism and nutrition disorders Creatinine	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Metabolism and nutrition disorders Lab - Other	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Musculoskeletal and connective tissue disorders Lumbar Spine Range of Mobility Decrease	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	40.0% 2/5 • Number of events 2 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Nervous system disorders Neuropathy - Motor	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Nervous system disorders Neuropathy - Sensory	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Musculoskeletal and connective tissue disorders Pain - Back	16.7% 1/6 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	0.00% 0/5 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Musculoskeletal and connective tissue disorders Pain - Limb	33.3% 2/6 • Number of events 2 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	0.00% 0/5 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Renal and urinary disorders Renal - Other	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	0.00% 0/5 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
General disorders Pain - Other	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/6 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months	20.0% 1/5 • Number of events 1 • Adverse event collection from baseline to 30 days following discontinuation of study drug. Overall study period: 2 years and 6 months