Trial Outcomes & Findings for A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer (NCT NCT00584012)
NCT ID: NCT00584012
Last Updated: 2018-10-19
Results Overview
To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
27 weeks
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
Dose Esclation
Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dose Esclation
Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study was terminated prior to completion.
Baseline characteristics by cohort
| Measure |
Dose Esclation
n=9 Participants
Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Study was terminated prior to completion.
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants • Study was terminated prior to completion.
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants • Study was terminated prior to completion.
|
|
Age, Continuous
|
56.1 years
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants • Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
|
PRIMARY outcome
Timeframe: 27 weeksPopulation: Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.
To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors.
Outcome measures
Outcome data not reported
Adverse Events
Dose Esclation
Serious events: 1 serious events
Other events: 9 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dose Esclation
n=9 participants at risk
Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2.
|
|---|---|
|
Cardiac disorders
Cardiovascular (Arrhythmia)
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Kidney Stone
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Dose Esclation
n=9 participants at risk
Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.
Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2.
|
|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
6/9 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Thrombocytopenia
|
33.3%
3/9 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Indigestion
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Amylase
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Fatigue
|
77.8%
7/9 • Number of events 7
|
|
General disorders
Headache
|
22.2%
2/9 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
22.2%
2/9 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
3/9 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hemmorrhage, nose
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain, scalp
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Small bowel obstruction
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
3/9 • Number of events 6
|
|
Metabolism and nutrition disorders
Decreased bicarbonate
|
33.3%
3/9 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Anemia
|
44.4%
4/9 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Vomitting
|
44.4%
4/9 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain, shoulder
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Flushing, face
|
44.4%
4/9 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
44.4%
4/9 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • Number of events 3
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 2
|
|
Cardiac disorders
Atrial Fibrillation
|
22.2%
2/9 • Number of events 2
|
|
Infections and infestations
Infection with normal ANC
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
44.4%
4/9 • Number of events 4
|
|
Eye disorders
Occular/visual, peripheral light pulsing
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated CPK
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated ALT
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Elevated AST
|
11.1%
1/9 • Number of events 1
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
33.3%
3/9 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspenea on exertion
|
55.6%
5/9 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain, cramps
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Neutropenia
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, ankle
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.4%
4/9 • Number of events 4
|
|
Blood and lymphatic system disorders
Decreased WBC
|
44.4%
4/9 • Number of events 5
|
|
Cardiac disorders
Edema
|
55.6%
5/9 • Number of events 8
|
|
Immune system disorders
Hypersensitivity reaction
|
22.2%
2/9 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain/tenderness, periorbital region
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain/cramping, leg
|
22.2%
2/9 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain, hands
|
33.3%
3/9 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Pain, oral cavity
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Insomnia
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Dysgeusia
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Koilonychia
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Blurred vision
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
22.2%
2/9 • Number of events 2
|
|
Renal and urinary disorders
Elevated creatinine
|
11.1%
1/9 • Number of events 1
|
|
Hepatobiliary disorders
Elevated Alkaline phosphatase
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
11.1%
1/9 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
33.3%
3/9 • Number of events 3
|
|
Psychiatric disorders
Mood alteration, depression
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Decreased appetite, anorexia
|
22.2%
2/9 • Number of events 2
|
|
Nervous system disorders
Dizziness/lightheadedness
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distention
|
11.1%
1/9 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, chest (muscular)
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus skin breakdown, gluteal folds
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, neck
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture, iliac wing
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Fall
|
11.1%
1/9 • Number of events 2
|
|
General disorders
Weight gain
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain, chest/thoracic
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash, facial
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash, palmar
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
UTI
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint achiness
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, knee
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Gastric reflux
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Urine color change
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated glucose
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased netrophils
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, hip
|
11.1%
1/9 • Number of events 1
|
Additional Information
Cena Jones-Bitterman
Holden Comprehensive Cancer Center
Phone: 319-353-4596
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place