Trial Outcomes & Findings for A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer (NCT NCT00585052)
NCT ID: NCT00585052
Last Updated: 2018-01-05
Results Overview
Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional techniques. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow up. Image based evaluation is preferred to evaluation by clinical examination * Clinical Examination: Clinically detected lesions will only be considered measurable when they are superficial (e.g. skin nodules and palpable lymph nodes.) * Image based evaluation (CT and MRI): Conventional CT and MRI are currently the most reproducible methods of measuring lesions for response assessment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-01-05
Participant Flow
Participant milestones
| Measure |
Paclitaxel and Lovastatin
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Paclitaxel and Lovastatin
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel and Lovastatin
n=11 Participants
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
61.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksLesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional techniques. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow up. Image based evaluation is preferred to evaluation by clinical examination * Clinical Examination: Clinically detected lesions will only be considered measurable when they are superficial (e.g. skin nodules and palpable lymph nodes.) * Image based evaluation (CT and MRI): Conventional CT and MRI are currently the most reproducible methods of measuring lesions for response assessment.
Outcome measures
| Measure |
Paclitaxel and Lovastatin
n=10 Participants
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.
|
|---|---|
|
Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.
Complete Response (CR)
|
0 Participants
|
|
Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.
Partial Response (PR)
|
0 Participants
|
|
Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.
Stable Disease (SD)
|
0 Participants
|
|
Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.
Progressive Disease (PD)
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to one yearTo determine the time to progression using the combination of lovastatin and paclitaxel.
Outcome measures
| Measure |
Paclitaxel and Lovastatin
n=10 Participants
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.
|
|---|---|
|
Time to Progression Using the Combination of Lovastatin and Paclitaxel.
|
0.41 years
Standard Deviation 0.202
|
Adverse Events
Paclitaxel and Lovastatin
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel and Lovastatin
n=10 participants at risk
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.
|
|---|---|
|
Gastrointestinal disorders
Partial small bowel obstruction
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 3
|
|
Hepatobiliary disorders
Increased liver functions
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distention and discomfort
|
10.0%
1/10 • Number of events 1
|
|
Hepatobiliary disorders
Myelodysplasia
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Paclitaxel and Lovastatin
n=10 participants at risk
Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.
Paclitaxel: Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
Lovastatin: Lovastatin, 80 mg, po, daily will be self-administered by the subject.
|
|---|---|
|
General disorders
Nail changes
|
30.0%
3/10 • Number of events 3
|
|
Nervous system disorders
Neuropathy
|
70.0%
7/10 • Number of events 16
|
|
General disorders
Loss of balance
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Sleeplessness
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
4/10 • Number of events 6
|
|
Infections and infestations
Cold
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
20.0%
2/10 • Number of events 3
|
|
Infections and infestations
Sinus infection
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
7/10 • Number of events 16
|
|
Blood and lymphatic system disorders
Pedal edema
|
40.0%
4/10 • Number of events 4
|
|
Eye disorders
Eye tearing
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Fatigue
|
80.0%
8/10 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • Number of events 17
|
|
General disorders
Headache
|
50.0%
5/10 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Right upper quadrant pain
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Alopecia
|
90.0%
9/10 • Number of events 10
|
|
General disorders
Lightheadedness
|
20.0%
2/10 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
80.0%
8/10 • Number of events 8
|
|
Gastrointestinal disorders
Decreased appetite
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Small bowel obstruction
|
20.0%
2/10 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
20.0%
2/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Axillary, benign mass
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Breast, benign mass
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
3/10 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
4/10 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Side pain
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Bloating
|
50.0%
5/10 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal cramping/pain
|
70.0%
7/10 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3
|
|
Renal and urinary disorders
Hydronephrosis
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urinary urgency
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Hot flashes
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
4/10 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Shingles
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
40.0%
4/10 • Number of events 4
|
|
General disorders
Night sweats
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
30.0%
3/10 • Number of events 3
|
|
General disorders
Pain
|
40.0%
4/10 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
10.0%
1/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
3/10 • Number of events 4
|
|
General disorders
Facial swelling
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
2/10 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Eye/cheek swelling
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tightness
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Early satiety/fullness
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Nail bed fungal infection
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract infection
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Fingernail/nail bed discoloration
|
40.0%
4/10 • Number of events 4
|
|
Gastrointestinal disorders
Ascites
|
30.0%
3/10 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Burn to fingers
|
30.0%
3/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Leg jumpiness
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Anorexia
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Taste disturbance
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Sore tongue
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Blurred vision
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Mouth dryness
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urosepsis
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Lukopenia
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
20.0%
2/10 • Number of events 2
|
|
Renal and urinary disorders
Bladder infection
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Itchiness, mild skin infection
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Fingernail pain
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Toe pain
|
10.0%
1/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Ankle edema
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Food allergy
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Bloody nasal drainage
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
1/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Overheating
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
20.0%
2/10 • Number of events 3
|
|
General disorders
Dehydration
|
20.0%
2/10 • Number of events 4
|
|
Blood and lymphatic system disorders
Periorbital edema
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Erythema eyelid
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal drainage
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Decreased oral intake
|
10.0%
1/10 • Number of events 4
|
|
General disorders
Chills/sweats
|
10.0%
1/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Ankle swelling
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Hand swelling
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Ecchymosis
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema (generalized)
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Peripheral edema
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Epigastric pain
|
10.0%
1/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Eyelid irritation
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place