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Trial record 24 of 880 for:    LENALIDOMIDE

Gemcitabine, Cisplatin, Plus Lenalidomide as First-line Therapy for Patients With Metastatic Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT01342172
Recruitment Status : Terminated (low accrual)
First Posted : April 27, 2011
Results First Posted : November 26, 2014
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Matthew Galsky, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urinary Bladder Neoplasms
Intervention Drug: Lenalidomide
Enrollment 9
Recruitment Details The study opened to accrual at the Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah; the National Cancer Institute, Bethesda, Maryland;, and the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NewYork over the course of 19 months.
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Lenalidomide
Hide Arm/Group Description lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
69
(44 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
3
  33.3%
Male
6
  66.7%
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
0
0
   0.0%
1
8
  88.9%
2
1
  11.1%
[1]
Measure Description:

Eastern Cooperative Oncology Group (ECOG) Performance Status:

0 - Fully active, able to carry on all pre-disease performance without restriction

  1. - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Lenalidomide
Hide Description MTD was determined by testing planned increasing doses up to 25 mg daily dose on days 1-14, starting at 10mg. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any lenalidomide-related Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) Grade 3 or 4 adverse events
Time Frame after 1 cycle (each cycle is 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The dose of lenalidomide was not escalated beyond 10 mg because of cytopenias requiring repeated dose delays and reductions.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: mg
10
2.Primary Outcome
Title Phase II: Progression-free Survival at 1 Year
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The Objective Response Rate to Treatment With Gemcitabine, Cisplatin, Plus Lenalidomide
Hide Description

The objective response rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST).

Complete Response (CR) Disappearance of all target lesions for a period of at least one month.

Partial Response (PR) At least a 30% decrease in the sum of the longest diameter of measures lesions (target lesions), taking as reference the baseline sum of the longest diameter.

Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started.

Progressive Disease (PD) A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Time Frame After 2 cycles (a cycle is 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
CR
1
  11.1%
PR
2
  22.2%
SD
3
  33.3%
PD
2
  22.2%
not evaluable
1
  11.1%
4.Secondary Outcome
Title Number of Grade >=3 Adverse Events
Hide Description Number of grade >=3 adverse events to assess the safety of combination therapy with gemcitabine, cisplatin plus lenalidomide as determined by the frequency and severity of adverse events as per the NCI Common Terminology for Adverse Events (CTCAE) version 4.0.
Time Frame Day 1 and Day 8 of each treatment cycle; 21 days after the last dose of Lenalidomide
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: events
Grade 3 28
Grade 4 7
5.Secondary Outcome
Title Best Overall Response
Hide Description

Best Overall Response to evaluate lenalidomide as maintenance treatment in patients achieving an objective response of either complete response or partial response following completion of 6 cycles of combination therapy.

Complete Response (CR) - CR of target lesions and no new lesions Partial Response (PR) -PR of target lesions and no new lesions Stable Disease (SD) - SD of target lesions and no new lesions Progression Disease (PD) - any status of target lesions and new lesions

Time Frame 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
CR
1
  11.1%
PR
2
  22.2%
6.Secondary Outcome
Title To Determine the Impact of Treatment on Peripheral Blood Immune Cell Subsets
Time Frame Day 1 of Cycle 0 and Day 1 of Cycle 2 (each Cycle is 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title To Determine the Impact of Treatment on Circulating Tumor Cells
Hide Description Circulating epithelial tumor cells (CTC) will be investigated as an experimental endpoint using immunofluorescence techniques and CTC identification by positive expression of epithelial markers and a viability marker and negative expression of hematopoietic markers. These analyses will only be done in the phase II portion of the protocol.
Time Frame Day 1 of Cycles 0, 1 and 2 (each Cycle is 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data collected over the course of 19 months
Adverse Event Reporting Description Listed are adverse events with grade 3 or higher
 
Arm/Group Title Lenalidomide for Cycle 1 Phase 2
Hide Arm/Group Description lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
All-Cause Mortality
Lenalidomide for Cycle 1 Phase 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide for Cycle 1 Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      0/9 (0.00%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/9 (11.11%)  1 0/9 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide for Cycle 1 Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/9 (100.00%)      9/9 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  3/9 (33.33%)  3 1/9 (11.11%) 
Leukopenia  1  3/9 (33.33%)  3 2/9 (22.22%) 
Neutropenia  1  7/9 (77.78%)  7 0/9 (0.00%) 
Pancytopenia  1  1/9 (11.11%)  1 0/9 (0.00%) 
thrombocytopenia  1  4/9 (44.44%)  4 5/9 (55.56%) 
Leukopenia  1  3/9 (33.33%)  2/9 (22.22%) 
Cardiac disorders     
Syncope  1  0/9 (0.00%)  1/9 (11.11%) 
Tachycardia  1  0/9 (0.00%)  2/9 (22.22%) 
Ear and labyrinth disorders     
Hearing Loss  1  0/9 (0.00%)  2/9 (22.22%) 
Tinnitus  1  0/9 (0.00%)  2/9 (22.22%) 
Eye disorders     
Blurred Vision  1  1/9 (11.11%)  1 0/9 (0.00%) 
Watering eye left  1  0/9 (0.00%)  1/9 (11.11%) 
Gastrointestinal disorders     
Abdominal Pain  1  1/9 (11.11%)  1 2/9 (22.22%) 
Diarrhea  1  2/9 (22.22%)  2 6/9 (66.67%) 
Angular Chelitis  1  1/9 (11.11%)  0/9 (0.00%) 
Anorexia  1  0/9 (0.00%)  3/9 (33.33%) 
C. difficile infection  1  0/9 (0.00%)  1/9 (11.11%) 
Constipation  1  0/9 (0.00%)  7/9 (77.78%) 
Dry Mouth  1  0/9 (0.00%)  1/9 (11.11%) 
Mouth sores  1  0/9 (0.00%)  2/9 (22.22%) 
Mucositis  1  0/9 (0.00%)  1/9 (11.11%) 
Nausea  1  0/9 (0.00%)  8/9 (88.89%) 
Oral Thrush  1  0/9 (0.00%)  1/9 (11.11%) 
Vomiting  1  0/9 (0.00%)  8/9 (88.89%) 
General disorders     
ALP/ALT increase  1  1/9 (11.11%)  1 1/9 (11.11%) 
Fatigue  1  1/9 (11.11%)  1 4/9 (44.44%) 
Bone pain  1 [1]  0/9 (0.00%)  1/9 (11.11%) 
Cold  1  0/9 (0.00%)  2/9 (22.22%) 
Dizziness  1  0/9 (0.00%)  4/9 (44.44%) 
Edema  1  0/9 (0.00%)  4/9 (44.44%) 
Fever  1  0/9 (0.00%)  1/9 (11.11%) 
Flu-like symptoms  1  0/9 (0.00%)  1/9 (11.11%) 
Hand Tremors  1  0/9 (0.00%)  1/9 (11.11%) 
Hypertension  1  0/9 (0.00%)  1/9 (11.11%) 
Lightheadedness  1  0/9 (0.00%)  1/9 (11.11%) 
Loss of appetitie  1  0/9 (0.00%)  1/9 (11.11%) 
Lower back pain  1  0/9 (0.00%)  1/9 (11.11%) 
Pain extremities  1  0/9 (0.00%)  4/9 (44.44%) 
Pruritus  1  0/9 (0.00%)  1/9 (11.11%) 
Rhinorrhea  1  0/9 (0.00%)  1/9 (11.11%) 
Sore Throat  1  0/9 (0.00%)  1/9 (11.11%) 
Taste alteration  1  0/9 (0.00%)  2/9 (22.22%) 
Weakness  1  0/9 (0.00%)  1/9 (11.11%) 
Hepatobiliary disorders     
Ascending Cholangitis  1  1/9 (11.11%)  1 0/9 (0.00%) 
Immune system disorders     
Febrile neutropenia  1  1/9 (11.11%)  1 0/9 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/9 (11.11%)  1 0/9 (0.00%) 
Hypocalcemia  1  1/9 (11.11%)  1 0/9 (0.00%) 
Hypokalemia  1  1/9 (11.11%)  1 2/9 (22.22%) 
Hypomagnesium  1  1/9 (11.11%)  1 0/9 (0.00%) 
Hyponatremia  1  1/9 (11.11%)  1 0/9 (0.00%) 
Hypercalcemia  1  0/9 (0.00%)  1/9 (11.11%) 
Hyperkalemia  1  0/9 (0.00%)  1/9 (11.11%) 
Hypernatremia  1  0/9 (0.00%)  1/9 (11.11%) 
Hypoalbuminemia  1  0/9 (0.00%)  2/9 (22.22%) 
Nervous system disorders     
Confusion  1  1/9 (11.11%)  1 0/9 (0.00%) 
Hydrocephalus  1  0/9 (0.00%)  1/9 (11.11%) 
Neuropathy  1  0/9 (0.00%)  6/9 (66.67%) 
Right-heel numbness  1  0/9 (0.00%)  1/9 (11.11%) 
Renal and urinary disorders     
Urinary tract infection  1  1/9 (11.11%)  1 3/9 (33.33%) 
Creatinine increased  1  0/9 (0.00%)  4/9 (44.44%) 
Hematuria  1  0/9 (0.00%)  3/9 (33.33%) 
Urinary frequency  1  0/9 (0.00%)  1/9 (11.11%) 
Urinary hesitancy  1  0/9 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/9 (0.00%)  5/9 (55.56%) 
Dyspnea  1  0/9 (0.00%)  2/9 (22.22%) 
Hypoxia  1  0/9 (0.00%)  1/9 (11.11%) 
Shortness of breath  1  0/9 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders     
Erythematous rash  1  0/9 (0.00%)  1/9 (11.11%) 
Vascular disorders     
Phlebitis  1 [2]  0/9 (0.00%)  2/9 (22.22%) 
Thromboembolism  1  0/9 (0.00%)  4/9 (44.44%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
right midthigh and all pain
[2]
left lower leg
The trial was terminated because the regimen was deemed poorly tolerated for chronic administration because of the need for repeated dose delays and reductions coupled with slow accrual.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Matthew Galsky
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-8816
Responsible Party: Matthew Galsky, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01342172     History of Changes
Obsolete Identifiers: NCT01441050
Other Study ID Numbers: GCO 10-1339
First Submitted: April 21, 2011
First Posted: April 27, 2011
Results First Submitted: November 20, 2014
Results First Posted: November 26, 2014
Last Update Posted: April 23, 2019