Trial Outcomes & Findings for Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer That Did Not Respond to Previous Oxaliplatin, Fluoropyrimidine, and Bevacizumab (NCT NCT00588900)

Last Updated: 2017-04-05

Results Overview

The 12 week progression-free rate was defined as the percentage of patients that were alive and progression-free 12 weeks after start of second-line therapy. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

at 12 weeks

Results posted on

2017-04-05

Participant Flow

Between March 2008 and May 2010, 5 participants were registered.

Participant milestones

Participant milestones
Measure	Irinotecan + Cediranib Participants receive irinotecan hydrochloride 125 mg/m\^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Irinotecan and Cediranib in Treating Patients With Metastatic Colorectal Cancer That Did Not Respond to Previous Oxaliplatin, Fluoropyrimidine, and Bevacizumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Irinotecan + Cediranib n=5 Participants Participants receive irinotecan hydrochloride 125 mg/m\^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Age, Continuous	69.9 years n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	5 participants n=99 Participants

PRIMARY outcome

Timeframe: at 12 weeks

Outcome measures

Outcome measures
Measure	Irinotecan + Cediranib n=5 Participants Participants receive irinotecan hydrochloride 125 mg/m\^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
The Percentage of Patients Who Are Progression-free at 12 Weeks From the Start of Second-line Therapy	60 percentage of participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.

The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Study terminated prematurely; due to patient confidentiality concerns this planned analysis was not performed.

Overall Survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

Adverse Events

Irinotecan + Cediranib

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Irinotecan + Cediranib n=4 participants at risk Participants receive irinotecan hydrochloride 125 mg/m\^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin decreased	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Colitis	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Diarrhea	50.0% 2/4 • Number of events 2 4 participants were evaluable for adverse events.
Gastrointestinal disorders Enteritis	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Stomach pain	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
General disorders Fatigue	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
General disorders Fever	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Investigations INR increased	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Investigations Neutrophil count decreased	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Investigations Platelet count decreased	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Investigations Weight loss	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Nervous system disorders Seizure	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.

Other adverse events

Other adverse events
Measure	Irinotecan + Cediranib n=4 participants at risk Participants receive irinotecan hydrochloride 125 mg/m\^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Blood disorder	50.0% 2/4 • Number of events 4 4 participants were evaluable for adverse events.
Blood and lymphatic system disorders Febrile neutropenia	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Blood and lymphatic system disorders Hemoglobin decreased	25.0% 1/4 • Number of events 2 4 participants were evaluable for adverse events.
Cardiac disorders Atrial fibrillation	25.0% 1/4 • Number of events 2 4 participants were evaluable for adverse events.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 4 4 participants were evaluable for adverse events.
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Diarrhea	100.0% 4/4 • Number of events 18 4 participants were evaluable for adverse events.
Gastrointestinal disorders Flatulence	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Gastritis	25.0% 1/4 • Number of events 2 4 participants were evaluable for adverse events.
Gastrointestinal disorders Ileus	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Nausea	100.0% 4/4 • Number of events 7 4 participants were evaluable for adverse events.
Gastrointestinal disorders Stomach pain	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Gastrointestinal disorders Vomiting	50.0% 2/4 • Number of events 2 4 participants were evaluable for adverse events.
General disorders Fatigue	75.0% 3/4 • Number of events 10 4 participants were evaluable for adverse events.
Hepatobiliary disorders Hepatic pain	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Investigations Alanine aminotransferase increased	50.0% 2/4 • Number of events 4 4 participants were evaluable for adverse events.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 4 4 participants were evaluable for adverse events.
Investigations INR increased	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Investigations Laboratory test abnormal	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Investigations Leukocyte count decreased	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Investigations Neutrophil count decreased	75.0% 3/4 • Number of events 10 4 participants were evaluable for adverse events.
Investigations Platelet count decreased	50.0% 2/4 • Number of events 12 4 participants were evaluable for adverse events.
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Number of events 2 4 participants were evaluable for adverse events.
Metabolism and nutrition disorders Blood glucose increased	25.0% 1/4 • Number of events 6 4 participants were evaluable for adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Nervous system disorders Peripheral sensory neuropathy	25.0% 1/4 • Number of events 4 4 participants were evaluable for adverse events.
Nervous system disorders Seizure	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Renal and urinary disorders Proteinuria	25.0% 1/4 • Number of events 6 4 participants were evaluable for adverse events.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 2 4 participants were evaluable for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 2 4 participants were evaluable for adverse events.
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • Number of events 5 4 participants were evaluable for adverse events.
Skin and subcutaneous tissue disorders Skin disorder	25.0% 1/4 • Number of events 1 4 participants were evaluable for adverse events.
Vascular disorders Hypertension	25.0% 1/4 • Number of events 4 4 participants were evaluable for adverse events.
Vascular disorders Thrombosis	25.0% 1/4 • Number of events 4 4 participants were evaluable for adverse events.

Additional Information

Bert O'Neil, M.D.

UNC Lineberger Comprehensive Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60