Trial Outcomes & Findings for Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors (NCT NCT00957905)
NCT ID: NCT00957905
Last Updated: 2017-03-10
Results Overview
Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria" (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Within 3 courses of treatment
Results posted on
2017-03-10
Participant Flow
Participant milestones
| Measure |
Part A
6 weeks: Flavopiridol: 70 mg/m2/day IV over 1 hr on days 1, 15 and 29. Oxaliplatin: 85 mg/m2/day IV over 2 hrs on days 1, 15 and 29.
|
Part B
6 wks: Flavopiridol:70 mg/m2/day IV 1 hr Days 1, 15 \& 29. Oxaliplatin:85 mg/m2/day IV 2 hrs Days 1, 15 \& 29. Leucovorin:400 mg/m2/day IV 2 hrs Days 1, 15 \& 29.
5-FU: 400 mg/m2 IV 15 min, and 1800 mg/m2 IV 48 hrs Days 1-2, 15-16 \& 29-30.
|
|---|---|---|
|
Part A
STARTED
|
7
|
0
|
|
Part A
COMPLETED
|
7
|
0
|
|
Part A
NOT COMPLETED
|
0
|
0
|
|
Part B
STARTED
|
0
|
29
|
|
Part B
COMPLETED
|
0
|
25
|
|
Part B
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Part A
6 weeks: Flavopiridol: 70 mg/m2/day IV over 1 hr on days 1, 15 and 29. Oxaliplatin: 85 mg/m2/day IV over 2 hrs on days 1, 15 and 29.
|
Part B
6 wks: Flavopiridol:70 mg/m2/day IV 1 hr Days 1, 15 \& 29. Oxaliplatin:85 mg/m2/day IV 2 hrs Days 1, 15 \& 29. Leucovorin:400 mg/m2/day IV 2 hrs Days 1, 15 \& 29.
5-FU: 400 mg/m2 IV 15 min, and 1800 mg/m2 IV 48 hrs Days 1-2, 15-16 \& 29-30.
|
|---|---|---|
|
Part B
Not Treated
|
0
|
1
|
|
Part B
Physician Decision
|
0
|
1
|
|
Part B
Death
|
0
|
1
|
|
Part B
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Baseline characteristics by cohort
| Measure |
Part A (Alvocidib and Oxaliplatin)
n=7 Participants
Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
Part B (Alvocidib and FOLFOX)
n=29 Participants
Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
29 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 3 courses of treatmentNumber of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria" (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Part A (Alvocidib and Oxaliplatin)
n=7 Participants
Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
Part B (Alvocidib and FOLFOX)
n=25 Participants
Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rate
Partial Response
|
0 participants
|
6 participants
|
|
Objective Response Rate
Stable Disease
|
2 participants
|
10 participants
|
|
Objective Response Rate
Progression of Disease
|
5 participants
|
9 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 yearsgraded using the NCI CTCAE version 4.0.See adverse event section
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From treatment start until first documented progression or death, assessed up to 4 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From treatment start until first documented CR or PR, assessed up to 4 yearsOutcome measures
Outcome data not reported
Adverse Events
Part A (Alvocidib and Oxaliplatin)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B (Alvocidib and FOLFOX)
Serious events: 7 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A (Alvocidib and Oxaliplatin)
n=7 participants at risk
Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
Part B (Alvocidib and FOLFOX)
n=29 participants at risk
Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Nervous system disorders
Intracranial hemorrhage
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Infections and infestations
Infective myositis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
|
28.6%
2/7 • Number of events 2
|
0.00%
0/29
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Investigations
Platelet count decrease
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7
|
3.4%
1/29 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/7
|
6.9%
2/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/7
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7
|
3.4%
1/29 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.00%
0/7
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/7
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Part A (Alvocidib and Oxaliplatin)
n=7 participants at risk
Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
Part B (Alvocidib and FOLFOX)
n=29 participants at risk
Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
28.6%
2/7 • Number of events 5
|
6.9%
2/29 • Number of events 7
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
2/7 • Number of events 18
|
27.6%
8/29 • Number of events 46
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Number of events 3
|
0.00%
0/29
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • Number of events 3
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1
|
13.8%
4/29 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1
|
17.2%
5/29 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 1
|
13.8%
4/29 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Number of events 12
|
20.7%
6/29 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Number of events 2
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
1/7 • Number of events 13
|
20.7%
6/29 • Number of events 15
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/29
|
|
Investigations
Lymphocyte count decreased
|
28.6%
2/7 • Number of events 10
|
34.5%
10/29 • Number of events 39
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Number of events 1
|
41.4%
12/29 • Number of events 39
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • Number of events 3
|
58.6%
17/29 • Number of events 60
|
|
Investigations
White blood cell decreased
|
28.6%
2/7 • Number of events 6
|
41.4%
12/29 • Number of events 55
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/7
|
6.9%
2/29 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/7
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Fatigue
|
0.00%
0/7
|
13.8%
4/29 • Number of events 6
|
|
Investigations
INR increased
|
0.00%
0/7
|
6.9%
2/29 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
|
27.6%
8/29 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
|
24.1%
7/29 • Number of events 10
|
Additional Information
Dr. Darren Feldman
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4491
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60