Trial Outcomes & Findings for Pharmacokinetics of Daunorubicin in Young Patients With Cancer (NCT NCT00673257)

Last Updated: 2020-04-14

Results Overview

Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.

Recruitment status

COMPLETED

Study phase

Target enrollment

107 participants

Primary outcome timeframe

Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.

Results posted on

2020-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Pharmacokinetics of Daunorubicin Chemotherapy Patients Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Overall Study STARTED	107
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Pharmacokinetics of Daunorubicin Chemotherapy Patients Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Overall Study Withdrawal by Subject	4
Overall Study Unable to obtain specimen	1

Baseline Characteristics

Pharmacokinetics of Daunorubicin in Young Patients With Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pharmacokinetics of Daunorubicin Chemotherapy Patients n=107 Participants Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Age, Categorical <=18 years	99 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	11.5 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	82 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.

Population: There were 107 patients enrolled, 4 participants withdrew consent and there was 1 patient with insufficient specimen. 4 other participants were not analyzed as all sample time points were required for analysis and were not available.

Outcome measures

Outcome measures
Measure	Pharmacokinetics of Daunorubicin Chemotherapy Patients n=98 Participants Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Population Estimates for Daunorubicin Hydrochloride Clearance	116 L/m2/hr Standard Deviation 14

PRIMARY outcome

Timeframe: Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.

Population: There were 107 patients enrolled, 4 participants withdrew consent and there was 1 participant with insufficient specimen. 4 other participants were not analyzed as all samples time points were required for analysis and were not available.

Outcome measures

Outcome measures
Measure	Pharmacokinetics of Daunorubicin Chemotherapy Patients n=98 Participants Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Population Estimates for Daunorubicin Hydrochloride Volume of Distribution	68.1 Liter Standard Deviation 24

Adverse Events

Pharmacokinetics of Daunorubicin Chemotherapy Patients

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pharmacokinetics of Daunorubicin Chemotherapy Patients n=107 participants at risk Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration \< 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Blood and lymphatic system disorders Bone marrow hypocellular	0.93% 1/107
Blood and lymphatic system disorders Anemia	24.3% 26/107
Blood and lymphatic system disorders White blood cell decreased	30.8% 33/107
Blood and lymphatic system disorders Lymphocyte count decreased	19.6% 21/107
Blood and lymphatic system disorders Neutrophil count decreased	28.0% 30/107
Blood and lymphatic system disorders Platelet count decreased	25.2% 27/107
Investigations Fibrinogen	1.9% 2/107
Metabolism and nutrition disorders Anorexia	2.8% 3/107
Metabolism and nutrition disorders Constipation	0.93% 1/107
Metabolism and nutrition disorders Diarrhea	1.9% 2/107
Metabolism and nutrition disorders Mucositis oral	0.93% 1/107
Metabolism and nutrition disorders Nausea	0.93% 1/107
Metabolism and nutrition disorders Proctitis	0.93% 1/107
Metabolism and nutrition disorders Vomiting	0.93% 1/107
Vascular disorders "Vascular disorders - Other, specify"	0.93% 1/107
Infections and infestations Enterocolitis infectious	0.93% 1/107
Infections and infestations Febrile neutropenia	8.4% 9/107
Infections and infestations "Infections and infestations - Other, specify"	8.4% 9/107
Metabolism and nutrition disorders Hypoalbuminemia	0.93% 1/107
Metabolism and nutrition disorders Alanine aminotransferase increased	7.5% 8/107
Metabolism and nutrition disorders Hypocalcemia	3.7% 4/107
Metabolism and nutrition disorders Hypercholestremia	0.93% 1/107
Metabolism and nutrition disorders GGT increased	0.93% 1/107
Metabolism and nutrition disorders Hyperglycemia	5.6% 6/107
Metabolism and nutrition disorders Lipase	1.9% 2/107
Metabolism and nutrition disorders Hypophosphatemia	0.93% 1/107
Metabolism and nutrition disorders Hyperkalemia	0.93% 1/107
Metabolism and nutrition disorders Hypokalemia	1.9% 2/107
Metabolism and nutrition disorders Hyponatremia	1.9% 2/107
Metabolism and nutrition disorders Hypertriglyceridemia	0.93% 1/107
Nervous system disorders Syncope	0.93% 1/107
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 2/107
Nervous system disorders Headache	0.93% 1/107
General disorders Pain	0.93% 1/107
Metabolism and nutrition disorders Tumor lysis syndrome	1.9% 2/107

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
Publication restrictions are in place

Restriction type: OTHER