Trial Outcomes & Findings for Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer (NCT NCT01320683)

NCT ID: NCT01320683

Last Updated: 2016-07-19

Results Overview

Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to 24 months

Results posted on

2016-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Combination Chemotherapy and Radioimmunotherapy) FOLFOX\* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:\*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Combination Chemotherapy and Radioimmunotherapy) FOLFOX\* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:\*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Positive antibody response	1

Baseline Characteristics

Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Combination Chemotherapy and Radioimmunotherapy) n=1 Participants FOLFOX\* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:\*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Age, Continuous	66 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Overall Survival is calculated for all patients from the date of initial treatment to date of death due to any cause. Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method, and 95% confidence limits calculated for these estimates.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Combination Chemotherapy and Radioimmunotherapy)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Combination Chemotherapy and Radioimmunotherapy) n=1 participants at risk FOLFOX\* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:\*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Investigations Activated partial thromboplastin time prolonged	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Metabolism and nutrition disorders Dehydration	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Nervous system disorders Dizziness	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Vascular disorders Hot flashes	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Metabolism and nutrition disorders Hypocalcemia	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Metabolism and nutrition disorders Hypoglycemia	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Metabolism and nutrition disorders Hyponatremia	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Investigations INR increased	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Investigations Lymphocyte count decreased	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Investigations Neutrophil count decreased	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Musculoskeletal and connective tissue disorders Pain in extremity	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Investigations Platelet count decreased	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Respiratory, thoracic and mediastinal disorders Postnasal drip	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Reproductive system and breast disorders Vaginal dryness	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Ear and labyrinth disorders Vestibular disorder	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Investigations Weight gain	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.
Investigations White blood cell decreased	100.0% 1/1 • Number of events 1 • Adverse events occurred over a two month period All adverse events are included regardless of grade and attribution.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place