Trial Outcomes & Findings for Docetaxel and Liposomal Doxorubicin Chemotherapy With Enoxaparin in Patients With Advanced Pancreatic Cancer (NCT NCT00426127)

NCT ID: NCT00426127

Last Updated: 2017-12-29

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 9 weeks
• Results posted on: 2017-12-29

Participant Flow

Participant milestones

Measure	Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg Docetaxel Liposomal Doxorubicin Enoxaparin
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg Docetaxel Liposomal Doxorubicin Enoxaparin
Overall Study Adverse Event	1
Overall Study Removed due to disease progression	1

Baseline Characteristics

Participants who received study treatment

Baseline characteristics by cohort

Measure	Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin n=2 Participants Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg Docetaxel Liposomal Doxorubicin Enoxaparin
Age, Categorical <=18 years	0 Participants n=5 Participants • Participants who received study treatment
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants • Participants who received study treatment
Age, Categorical >=65 years	1 Participants n=5 Participants • Participants who received study treatment
Age, Continuous	61.8 Years n=5 Participants • Participants who received study treatment
Sex: Female, Male Female	2 Participants n=5 Participants • Participants who received study treatment
Sex: Female, Male Male	0 Participants n=5 Participants • Participants who received study treatment
Region of Enrollment United States	2 participants n=5 Participants • Participants who received study treatment

PRIMARY outcome

Timeframe: 9 weeks

Population: One participant underwent 3 cycles of therapy and progressed as assessed by CT.

Outcome measures

Measure	Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin n=1 Participants Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg Docetaxel Liposomal Doxorubicin Enoxaparin
Tumor Response Measured by CT Scans After Each Set of 3 Cycles of Chemotherapy	1 Participants

SECONDARY outcome

Timeframe: 3 weeks

Population: 2 patients received at least one cycle of treatment and underwent blood draws testing D-Dimer levels

Incidence of elevated D-Dimer was defined as >.50 as drawn every cycle. Incidence of elevated D-Dimer was tested to determine safety and efficacy of the treatment regimen on patients with advanced pancreatic cancer.

Outcome measures

Measure	Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin n=2 Participants Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg Docetaxel Liposomal Doxorubicin Enoxaparin
Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle Incidences within normal range D-Dimer <.50	3 Blood draw
Number of Blood Draws With Incidence of Elevated D-Dimer Measured by Drawing D-Dimer Levels Every Cycle Incidence with elevated D-Dimer >.50	1 Blood draw

SECONDARY outcome

Timeframe: 3 weeks

Population: There was no analysis done

Outcome measures

Outcome data not reported

Adverse Events

Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Measure	Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin n=2 participants at risk Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg Docetaxel Liposomal Doxorubicin Enoxaparin
General disorders Disease progression	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.

Other adverse events

Measure	Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin n=2 participants at risk Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg Docetaxel Liposomal Doxorubicin Enoxaparin
Investigations Weight loss	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Immune system disorders Neutropenia	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Investigations Decreased white blood cell count	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Investigations Decreased hemoglobin	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Investigations Decreased calcium	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Investigations Decreased albumin	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Investigations Increased alk phosphatase	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Investigations Decreased sodium, intermittent	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Investigations Decreased phosphate	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Ascites, worsening recurrent	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Heartburn	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
General disorders Fatigue	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
General disorders Pedal edema	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Diarrhea	100.0% 2/2 • Number of events 2 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Infections and infestations Oral thrush	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Metabolism and nutrition disorders Hypokalemia	100.0% 2/2 • Number of events 3 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Psychiatric disorders Difficulty sleeping	50.0% 1/2 • Number of events 2 • All patients underwent a history and physical examination every 3 weeks during the therapy.
General disorders Injection site pain	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
General disorders Hand foot syndrome (red feet)	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Skin and subcutaneous tissue disorders Alopecia	100.0% 2/2 • Number of events 2 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Skin and subcutaneous tissue disorders Dry skin	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Infections and infestations Upper respiratory infection	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Vomitting	100.0% 2/2 • Number of events 2 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Oral mucositis	100.0% 2/2 • Number of events 3 • All patients underwent a history and physical examination every 3 weeks during the therapy.
General disorders Itching	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
General disorders Sensory neuropathy	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Respiratory, thoracic and mediastinal disorders Nasal sores	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Vascular disorders Hypotension	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Nervous system disorders Taste disturbance	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Eye disorders Dry eyes	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Dry mouth	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
General disorders Ecchymosis, injection site	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Skin and subcutaneous tissue disorders Rash	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
Renal and urinary disorders Urine discoloration	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.
General disorders Chills	50.0% 1/2 • Number of events 1 • All patients underwent a history and physical examination every 3 weeks during the therapy.

Additional Information

Daniel Berg, MD

University of Iowa

Phone: 319-353-7800

Email: daniel-j-berg@uiowa.edu

Results disclosure agreements

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