Trial Outcomes & Findings for Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery (NCT NCT00321828)

NCT ID: NCT00321828

Last Updated: 2024-03-21

Results Overview

Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2024-03-21

Participant Flow

Participant milestones

Measure	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Overall Study STARTED	90
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Overall Study Ineligible	3
Overall Study No follow up data	1

Baseline Characteristics

Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Measure	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=90 Participants Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Age, Continuous	59 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.

Outcome measures

Measure	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=86 Participants Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Major Morbidity Related to the Intact Primary Tumor	16.3 probability of major morbidity (%) Interval 7.6 to 25.1

SECONDARY outcome

Timeframe: Time from start of study through year 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from start of study through year 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from start of study through year 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from start of study through year 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from start of study through year 5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from start of study through year 5

Outcome measures

Outcome data not reported

Adverse Events

Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Serious events: 1 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=89 participants at risk Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Gastrointestinal disorders Diarrhea	1.1% 1/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.

Other adverse events

Measure	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=89 participants at risk Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Gastrointestinal disorders Abdominal pain	6.7% 6/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Immune system disorders Anaphylaxis	10.1% 9/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Blood and lymphatic system disorders Anemia	5.6% 5/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Anorexia	5.6% 5/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Dehydration	7.9% 7/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Diarrhea	7.9% 7/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.0% 8/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Fatigue	15.7% 14/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Nausea	6.7% 6/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Neutrophil count decreased	32.6% 29/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Peripheral sensory neuropathy	15.7% 14/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Thromboembolic event	11.2% 10/89 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations White blood cell decreased	6.7% 6/89 Participants at Risk includes any patient who submitted an Adverse Event (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