Trial Outcomes & Findings for Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer (NCT NCT00331682)
NCT ID: NCT00331682
Last Updated: 2014-05-28
Results Overview
Objective response rate as measured by RECIST criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2014-05-28
Participant Flow
Participant milestones
| Measure |
Docetaxel and Flavopiridol
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
alvocidib: Given IV
docetaxel: Given IV
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Docetaxel and Flavopiridol
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
alvocidib: Given IV
docetaxel: Given IV
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel and Flavopiridol
n=9 Participants
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV
|
|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 21.21320344 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsObjective response rate as measured by RECIST criteria
Outcome measures
| Measure |
Docetaxel and Flavopiridol
n=9 Participants
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV
|
|---|---|
|
Objective Response Rate as Measured by RECIST Criteria
Stable Disease
|
3 participants
|
|
Objective Response Rate as Measured by RECIST Criteria
Progression of Disease
|
6 participants
|
SECONDARY outcome
Timeframe: Between the start of treatment until the criteria for progression are met, assessed up to 2 yearsWill be computed using Kaplan-Meier methods.
Outcome measures
| Measure |
Docetaxel and Flavopiridol
n=9 Participants
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV
|
|---|---|
|
Time to Progression
|
8 weeks
Interval 7.0 to 14.0
|
SECONDARY outcome
Timeframe: Between the start of treatment until patient death, assessed up to 2 yearsWill be computed using Kaplan-Meier methods.
Outcome measures
| Measure |
Docetaxel and Flavopiridol
n=9 Participants
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV
|
|---|---|
|
Overall Survival
|
4.2 months
Interval 2.8 to 6.9
|
Adverse Events
Docetaxel and Flavopiridol
Serious events: 10 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel and Flavopiridol
n=9 participants at risk；n=10 participants at risk
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Death not associated w/ CTCAE term-Disease Progression NOS
|
20.0%
2/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Edema-visceral
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fatigue
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
2/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Anal hemorrhage
|
10.0%
1/10 • Number of events 1
|
|
Investigations
White blood cell decreased
|
40.0%
4/10 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
40.0%
4/10 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
40.0%
4/10 • Number of events 4
|
|
Gastrointestinal disorders
Colonic obstruction
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 2
|
Other adverse events
| Measure |
Docetaxel and Flavopiridol
n=9 participants at risk；n=10 participants at risk
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
flavopiridol: Given IV
docetaxel: Given IV
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
55.6%
5/9 • Number of events 5
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Cardiac troponin I increased
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Creatinine increased
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • Number of events 4
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
9/9 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
3/9 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
3/9 • Number of events 3
|
|
Investigations
INR increased
|
11.1%
1/9 • Number of events 1
|
|
Investigations
White blood cell decreased
|
66.7%
6/9 • Number of events 6
|
|
Investigations
Lymphocyte count decreased
|
55.6%
5/9 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
44.4%
4/9 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
3/9 • Number of events 3
|
|
Investigations
Platelet count decreased
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
2/9 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
11.1%
1/9 • Number of events 1
|
Additional Information
Dr. Eileen O'Reilly
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60