Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00957905
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Extragonadal Seminoma
Recurrent Malignant Extragonadal Germ Cell Tumor
Recurrent Malignant Extragonadal Non-Seminomatous Germ Cell Tumor
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Ovarian Germ Cell Tumor
Stage III Testicular Cancer
Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor
Stage IV Extragonadal Seminoma
Stage IV Ovarian Germ Cell Tumor
Interventions Drug: Alvocidib Hydrochloride
Drug: Fluorouracil
Drug: Leucovorin Calcium
Drug: Oxaliplatin
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A Part B
Hide Arm/Group Description 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.

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.
Period Title: Part A
Started 7 0
Completed 7 0
Not Completed 0 0
Period Title: Part B
Started 0 29
Completed 0 25
Not Completed 0 4
Reason Not Completed
Not Treated             0             1
Physician Decision             0             1
Death             0             1
Protocol Violation             0             1
Arm/Group Title Part A (Alvocidib and Oxaliplatin) Part B (Alvocidib and FOLFOX) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 7 29 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 29 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
29
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 29 participants 36 participants
Female
0
   0.0%
1
   3.4%
1
   2.8%
Male
7
 100.0%
28
  96.6%
35
  97.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 29 participants 36 participants
7 29 36
1.Primary Outcome
Title Objective Response Rate
Hide Description 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
Time Frame Within 3 courses of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part A (Alvocidib and Oxaliplatin) Part B (Alvocidib and FOLFOX)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 7 25
Measure Type: Number
Unit of Measure: participants
Partial Response 0 6
Stable Disease 2 10
Progression of Disease 5 9
2.Other Pre-specified Outcome
Title Toxicity
Hide Description graded using the NCI CTCAE version 4.0.See adverse event section
Time Frame Up to 4 years
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame From treatment start until first documented progression or death, assessed up to 4 years
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Time to Tumor Response
Hide Description [Not Specified]
Time Frame From treatment start until first documented CR or PR, assessed up to 4 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A (Alvocidib and Oxaliplatin) Part B (Alvocidib and FOLFOX)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Part A (Alvocidib and Oxaliplatin) Part B (Alvocidib and FOLFOX)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Part A (Alvocidib and Oxaliplatin) Part B (Alvocidib and FOLFOX)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/7 (57.14%)      7/29 (24.14%)    
Blood and lymphatic system disorders     
Anemia † 1  0/7 (0.00%)  0 2/29 (6.90%)  2
Cardiac disorders     
Cardiac arrest † 1  0/7 (0.00%)  0 1/29 (3.45%)  1
Gastrointestinal disorders     
Nausea † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Vomiting † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Abdominal pain † 1  0/7 (0.00%)  0 1/29 (3.45%)  1
General disorders     
Fever † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Multi-organ failure † 1  0/7 (0.00%)  0 1/29 (3.45%)  1
Non-cardiac chest pain † 1  0/7 (0.00%)  0 1/29 (3.45%)  1
Infections and infestations     
Infective myositis † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Sepsis † 1  0/7 (0.00%)  0 1/29 (3.45%)  1
Investigations     
Platelet count decrease † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Lymphocyte count decreased † 1  0/7 (0.00%)  0 1/29 (3.45%)  1
Metabolism and nutrition disorders     
Hypophosphatemia † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Hypokalemia † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Dehydration † 1  0/7 (0.00%)  0 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders     
Back pain † 1  0/7 (0.00%)  0 1/29 (3.45%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec † 1  2/7 (28.57%)  2 0/29 (0.00%)  0
Nervous system disorders     
Intracranial hemorrhage † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Headache † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A (Alvocidib and Oxaliplatin) Part B (Alvocidib and FOLFOX)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/7 (71.43%)      23/29 (79.31%)    
Blood and lymphatic system disorders     
Anemia † 1  2/7 (28.57%)  18 8/29 (27.59%)  46
Gastrointestinal disorders     
Diarrhea † 1  1/7 (14.29%)  1 4/29 (13.79%)  10
Nausea † 1  0/7 (0.00%)  0 8/29 (27.59%)  12
Vomiting † 1  0/7 (0.00%)  0 7/29 (24.14%)  10
General disorders     
Fatigue † 1  0/7 (0.00%)  0 4/29 (13.79%)  6
Investigations     
Alkaline phosphatase increased † 1  2/7 (28.57%)  5 2/29 (6.90%)  7
Blood bilirubin increased † 1  1/7 (14.29%)  3 0/29 (0.00%)  0
Creatinine increased † 1  1/7 (14.29%)  3 1/29 (3.45%)  1
Lymphocyte count decreased † 1  2/7 (28.57%)  10 10/29 (34.48%)  39
Neutrophil count decreased † 1  1/7 (14.29%)  1 12/29 (41.38%)  39
Platelet count decreased † 1  2/7 (28.57%)  3 17/29 (58.62%)  60
White blood cell decreased † 1  2/7 (28.57%)  6 12/29 (41.38%)  55
Activated partial thromboplastin time prolonged † 1  0/7 (0.00%)  0 2/29 (6.90%)  3
INR increased † 1  0/7 (0.00%)  0 2/29 (6.90%)  7
Metabolism and nutrition disorders     
Hyperglycemia † 1  1/7 (14.29%)  1 5/29 (17.24%)  10
Hypermagnesemia † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
Hypoalbuminemia † 1  1/7 (14.29%)  1 4/29 (13.79%)  9
Hypocalcemia † 1  1/7 (14.29%)  12 6/29 (20.69%)  16
Hypokalemia † 1  1/7 (14.29%)  2 1/29 (3.45%)  1
Hypophosphatemia † 1  1/7 (14.29%)  13 6/29 (20.69%)  15
Anorexia † 1  0/7 (0.00%)  0 2/29 (6.90%)  2
Psychiatric disorders     
Insomnia † 1  1/7 (14.29%)  1 0/29 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Darren Feldman
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-422-4491
EMail: feldmand@mskcc.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00957905    
Other Study ID Numbers: NCI-2011-01405
NCI-2011-01405 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-09034
CDR0000646950
09-034 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
8258 ( Other Identifier: CTEP )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
U01CA062491 ( U.S. NIH Grant/Contract )
U01CA062505 ( U.S. NIH Grant/Contract )
U01CA069856 ( U.S. NIH Grant/Contract )
U01CA069912 ( U.S. NIH Grant/Contract )
U01CA099168 ( U.S. NIH Grant/Contract )
First Submitted: August 12, 2009
First Posted: August 13, 2009
Results First Submitted: March 9, 2016
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017