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Trial record 59 of 2157 for:    doxorubicin

Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan

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ClinicalTrials.gov Identifier: NCT00720096
Recruitment Status : Terminated (Funds for this project have been spent, and it is thereby terminated.)
First Posted : July 22, 2008
Results First Posted : February 16, 2011
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: Liposomal Doxorubicin
Drug: Topotecan
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liposomal Doxorubicin Topotecan
Hide Arm/Group Description Liposomal Doxorubicin - Chemotherapy single agent systemic. Topotecan - Chemotherapy single agent systemic.
Period Title: Overall Study
Started 2 2
Completed 2 0
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Liposomal Doxorubicin Topotecan Total
Hide Arm/Group Description Liposomal Doxorubicin - Chemotherapy single agent systemic. Topotecan - Chemotherapy single agent systemic. Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
4
 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 2 participants 2 participants 4 participants
Female
2
 100.0%
2
 100.0%
4
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Assess Feasibility
Hide Description Number of patients meeting 3 week feasibility window which was set as the benchmark.
Time Frame 1 year, 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose information for treatment was available within the 3 week feasibility window which was set as the benchmark.
Arm/Group Title Liposomal Doxorubicin Topotecan
Hide Arm/Group Description:
Liposomal Doxorubicin - Chemotherapy single agent systemic.
Topotecan - Chemotherapy single agent systemic.
Overall Number of Participants Analyzed 2 2
Measure Type: Number
Unit of Measure: Participants
2 2
2.Primary Outcome
Title Interpret Genomic Array
Hide Description Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.
Time Frame 1 year, 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled 4/4 had biopsiable tumor and sufficient quantity and quality.
Arm/Group Title Liposomal Doxorubicin Topotecan
Hide Arm/Group Description:
Liposomal Doxorubicin - Chemotherapy single agent systemic.
Topotecan - Chemotherapy single agent systemic.
Overall Number of Participants Analyzed 2 2
Measure Type: Number
Unit of Measure: Participants
Biopsiable tumor: sufficient quantity and quality 2 2
Interpretable data 2 1
3.Secondary Outcome
Title Response Rate
Hide Description Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score >/= 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.
Time Frame 1 year, 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this Pilot study, due to small sample size and early termination.
Arm/Group Title Liposomal Doxorubicin Topotecan
Hide Arm/Group Description:
Liposomal Doxorubicin - Chemotherapy single agent systemic.
Topotecan - Chemotherapy single agent systemic.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year, 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liposomal Doxorubicin Topotecan
Hide Arm/Group Description Liposomal Doxorubicin - Chemotherapy single agent systemic. Topotecan - Chemotherapy single agent systemic.
All-Cause Mortality
Liposomal Doxorubicin Topotecan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Liposomal Doxorubicin Topotecan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      1/2 (50.00%)    
General disorders     
Fever combined with Anemia  1 [1]  0/2 (0.00%)  0 1/2 (50.00%)  1
Reproductive system and breast disorders     
Hospital Admission  1 [2]  1/2 (50.00%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
[1]
Topotecan Arm Patient – patient had a hospitalization for Grade 3 neutropenic fever Grade 3 anemia deemed related to Topotecan.
[2]
Pegylated Liposomal Doxorubicin (PLD) Arm Patient – patient had an SAE of hospital admission for observation due to tumor debulking done of a vaginal lesion that was deemed unrelated.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liposomal Doxorubicin Topotecan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      1/2 (50.00%)    
Blood and lymphatic system disorders     
Anemia  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Infection in blood  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Leukopenia  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Neutropenia  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Thrombocytopenia  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Gastrointestinal disorders     
Vomiting  1  1/2 (50.00%)  1 0/2 (0.00%)  0
General disorders     
Dizziness  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Fatigue  1  1/2 (50.00%)  1 1/2 (50.00%)  1
Headache  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Fever  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Syncope  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations     
Ant bite with infection  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  1/2 (50.00%)  1 1/2 (50.00%)  1
Renal and urinary disorders     
Increased creatinine  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders     
Shortage of breath  1  1/2 (50.00%)  1 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders     
Blister on left toe  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Blister on right toes  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Blister on right toe  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Blister on small toe left  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Hand foot reaction  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Hand foot syndrome  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Rash (chest)  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
Due to limited sample size, we were unable to make definitive conclusions in this trial.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Wenham, M.D., via Moffitt Cancer Center
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-4933
EMail: robert.wenham@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00720096     History of Changes
Other Study ID Numbers: MCC-15042
NFGC 12-12990-01-29 ( Other Identifier: NFGC )
First Submitted: July 21, 2008
First Posted: July 22, 2008
Results First Submitted: October 15, 2010
Results First Posted: February 16, 2011
Last Update Posted: January 2, 2018