Trial Outcomes & Findings for Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer (NCT NCT00268463)

NCT ID: NCT00268463

Last Updated: 2013-05-15

Results Overview

Time to first recurrence of colon cancer at any site

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 22 participants
• Primary outcome timeframe: Time from randomization through year 5
• Results posted on: 2013-05-15

Participant Flow

Participant milestones

Measure	Arm 1: Capecitabine + Oxaliplatin Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1 Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1	Arm 2: Floxuridine + Oxaliplatin + Capecitabine Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles
Overall Study STARTED	10	12
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Measure	Arm 1: Capecitabine + Oxaliplatin Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1 Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1	Arm 2: Floxuridine + Oxaliplatin + Capecitabine Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles
Overall Study study terminated due to low accrual	10	12

Baseline Characteristics

Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer

Baseline characteristics by cohort

Measure	Capecitabine + Oxaliplatin n=10 Participants Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine n=12 Participants Floxuridine + Oxaliplatin + Capecitabine	Total n=22 Participants Total of all reporting groups
Age Continuous	60 years STANDARD_DEVIATION 10.4 • n=5 Participants	59 years STANDARD_DEVIATION 9.4 • n=7 Participants	59 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex/Gender, Customized Female	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Sex/Gender, Customized Male	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Sex/Gender, Customized Unknown	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Time from randomization through year 5

Time to first recurrence of colon cancer at any site

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from randomization through year 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from randomization through year 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy

Outcome measures

Outcome data not reported

Adverse Events

Capecitabine + Oxaliplatin

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Floxuridine + Oxaliplatin + Capecitabine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Capecitabine + Oxaliplatin n=8 participants at risk Capecitabine + Oxaliplatin	Floxuridine + Oxaliplatin + Capecitabine n=6 participants at risk Floxuridine + Oxaliplatin + Capecitabine
Gastrointestinal disorders Abdominal pain	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	33.3% 2/6 Participants at Risk includes any patient who submitted an AE form.
Investigations Alanine aminotransferase increased (ALT/SGPT)	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Anorexia	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Investigations Aspartate aminotransferase increased (AST/SGOT)	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Investigations Blood bilirubin increased	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Eye disorders Blurred vision	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/6 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Constipation	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Dehydration	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Dental caries	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/6 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Diarrhea	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Dizziness	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Dysgeusia	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
General disorders Fatigue	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	33.3% 2/6 Participants at Risk includes any patient who submitted an AE form.
General disorders Fever	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperglycemia	25.0% 2/8 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/6 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Nausea	37.5% 3/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Investigations Neutrophil count decreased	25.0% 2/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Peripheral sensory neuropathy	37.5% 3/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Vomiting	25.0% 2/8 Participants at Risk includes any patient who submitted an AE form.	33.3% 2/6 Participants at Risk includes any patient who submitted an AE form.
Skin and subcutaneous tissue disorders Nail loss	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/6 Participants at Risk includes any patient who submitted an AE form.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Glucose intolerance	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/6 Participants at Risk includes any patient who submitted an AE form.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	12.5% 1/8 Participants at Risk includes any patient who submitted an AE form.	16.7% 1/6 Participants at Risk includes any patient who submitted an AE form.

Additional Information

Director, Division of Regulatory Affairs

NSABP Foundation, Inc.

Phone: 412-330-4600

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60