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Trial record 79 of 495 for:    LENALIDOMIDE AND every 28 days

Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT00903630
Recruitment Status : Terminated (lack of funding)
First Posted : May 18, 2009
Results First Posted : January 18, 2017
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions Drug: Lenalidomide
Drug: liposomal doxorubicin
Enrollment 15
Recruitment Details  
Pre-assignment Details Fifteen subjects were enrolled in this combined phase l/ll study - 11 subjects in phase l and 4 in phase ll. Six of the subjects enrolled in phase 1 were treated at the maximum tolerated dose (MTD) and their data was included in the phase 2 analysis as allowed by the protocol.
Arm/Group Title Phase 1 - Dose Level 1 Phase 1 - Dose Level 2 Phase 2 - Dose Level 1
Hide Arm/Group Description liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
Period Title: Phase l
Started 6 5 0
Completed 6 5 0
Not Completed 0 0 0
Period Title: Phase 2
Started 6 0 4
Completed 6 0 3 [1]
Not Completed 0 0 1
Reason Not Completed
Adverse Event             0             0             1
[1]
One participant was removed from the study after 2 weeks of treatment due to skin toxicity.
Arm/Group Title Phase 1 - Dose Level 1 Phase 1 - Dose Level 2 Phase 2 Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 6 5 4 15
Hide Baseline Analysis Population Description
One of the 4 subjects enrolled in the Phase 2 portion of the study was removed from the study 2 weeks after the start of treatment due to a skin rash leaving 9 evaluable subjects for the Phase 2 analysis. All 15 subjects from both the Phase 1 and Phase 2 portions of the trial were included in the Serious and Non-Serious Adverse Events analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 4 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  50.0%
3
  60.0%
3
  75.0%
9
  60.0%
>=65 years
3
  50.0%
2
  40.0%
1
  25.0%
6
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 4 participants 15 participants
Female
6
 100.0%
5
 100.0%
4
 100.0%
15
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 4 participants 15 participants
6 5 4 15
1.Primary Outcome
Title Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Hide Description The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).
Time Frame 1 cycle (28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide With Liposomal Doxorubicin
Hide Arm/Group Description:

Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.

Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle

pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: milligrams (mg)
10
2.Primary Outcome
Title Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Hide Description DLT is defined as the inability to complete cycle 1 and/or begin cycle 2 within 7 days of the planned start due to a grade 4 or greater hemtologic toxicity or a grade 3 or greater non-hematologic toxicity. Grading was based on Common Toxicity Criteria (CTC) Version 4.
Time Frame within 5 weeks of starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1 - Dose Level 1 Phase I - Dose Level 2 Phase 2
Hide Arm/Group Description:

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days

Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle

liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days

Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle

liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days

Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle

liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

Overall Number of Participants Analyzed 6 5 0
Measure Type: Number
Unit of Measure: participants
0 2
3.Primary Outcome
Title Phase 2 - Number of Subjects Achieving a Partial or Complete Response
Hide Description

Partial response is defined as:

At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.

Complete response is defined as:

The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.

Time Frame 3 months after starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1 - Dose Level 1 Phase I - Dose Level 2 Phase 2
Hide Arm/Group Description:

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days

Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle

liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days

Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle

liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days

Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle

liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

Overall Number of Participants Analyzed 0 0 9
Measure Type: Number
Unit of Measure: participants
1
4.Secondary Outcome
Title Phase 2 - Number of Subjects Who Are Progression-Free and Alive
Hide Description

Progression is defined as:

At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

Time Frame 3 months after starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide With Liposomal Doxorubicin
Hide Arm/Group Description:

Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.

Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle

pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
8
5.Secondary Outcome
Title Phase 2 - Number of Subjects Who Are Progression-Free and Alive
Hide Description

Progression is defined as:

At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurement, or the appearance of one or more new lesion(s).

Time Frame 6 months after starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide With Liposomal Doxorubicin
Hide Arm/Group Description:

Patients treated with a combination of lenalidomide and liposomal doxorubicin fpr recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.

Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle

pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 - Dose Level 1 Phase 1 - Dose Level 2 Phase 2
Hide Arm/Group Description

Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.

Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle

pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.

Lenalidomide: Administered by mouth at the assigned dose of 15 mg daily of each 28 day cycle

pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.

Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle

pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle

All-Cause Mortality
Phase 1 - Dose Level 1 Phase 1 - Dose Level 2 Phase 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1 - Dose Level 1 Phase 1 - Dose Level 2 Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/5 (20.00%)      1/4 (25.00%)    
Blood and lymphatic system disorders       
febrile neutropenia   0/6 (0.00%)  1/5 (20.00%)  1 0/4 (0.00%) 
General disorders       
fever   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  1
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 5%
Phase 1 - Dose Level 1 Phase 1 - Dose Level 2 Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      4/5 (80.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders       
Anemia   0/6 (0.00%)  1/5 (20.00%)  1/4 (25.00%) 
Endocrine disorders       
Hypothyroidism   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Eye disorders       
Blurred vision   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Gastrointestinal disorders       
Abdominal pain   2/6 (33.33%)  0/5 (0.00%)  2/4 (50.00%) 
Constipation   2/6 (33.33%)  2/5 (40.00%)  1/4 (25.00%) 
Diarrhea   1/6 (16.67%)  2/5 (40.00%)  1/4 (25.00%) 
Dry mouth   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Dyspepsia   1/6 (16.67%)  0/5 (0.00%)  1/4 (25.00%) 
Mucositis, oral   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Nausea   1/6 (16.67%)  0/5 (0.00%)  3/4 (75.00%) 
Stomach pain   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Toothache   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Vomiting   1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Anal pain   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
General disorders       
Edema, limbs   1/6 (16.67%)  0/5 (0.00%)  1/4 (25.00%) 
Fatigue   2/6 (33.33%)  3/5 (60.00%)  2/4 (50.00%) 
Pain NOS   0/6 (0.00%)  0/5 (0.00%)  2/4 (50.00%) 
Chills   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Infections and infestations       
Bronchial infection   1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Sinusitis   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Infection, toe   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Investigations       
Lymphocyte count decreased   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Neutrophil count decreased   2/6 (33.33%)  1/5 (20.00%)  2/4 (50.00%) 
Platelet count decreased   0/6 (0.00%)  1/5 (20.00%)  1/4 (25.00%) 
White blood cell count decreased   0/6 (0.00%)  0/5 (0.00%)  2/4 (50.00%) 
Metabolism and nutrition disorders       
Hypokalemia   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Dehydration   1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders       
Neck pain   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Muscle cramps, foot   1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Hip pain   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Nervous system disorders       
Ataxia   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Dizziness   0/6 (0.00%)  1/5 (20.00%)  1/4 (25.00%) 
Dysgeusia   1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Headache   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Peripheral sensory neuropathy   1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Psychiatric disorders       
Confusion   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Depression   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Insomnia   1/6 (16.67%)  0/5 (0.00%)  2/4 (50.00%) 
Renal and urinary disorders       
Burning with urination, intermittent   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Bladder discomfort NOS   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Dyspnea   1/6 (16.67%)  1/5 (20.00%)  0/4 (0.00%) 
Pharyngolaryngeal pain   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Shortness of breath with intermittent wheezing   1/6 (16.67%)  0/5 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia   1/6 (16.67%)  0/5 (0.00%)  1/4 (25.00%) 
Night sweats   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Plantar palmar erythrodysesthesia syndrome   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Rash maculopapular   1/6 (16.67%)  1/5 (20.00%)  1/4 (25.00%) 
Rash pruritic   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Red spots, hands   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Skin hyperpigmentation   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Skin pain   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Urticaria   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Pruritis   2/6 (33.33%)  0/5 (0.00%)  0/4 (0.00%) 
Rash, lower extremeities   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Vascular disorders       
Hypertension   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Hypotension   0/6 (0.00%)  1/5 (20.00%)  0/4 (0.00%) 
Phlebitis, arm   0/6 (0.00%)  0/5 (0.00%)  1/4 (25.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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. Levi Downs, Jr
Organization: University of Minnesota, Dept. of OBGYN
Phone: 612-626-3111
EMail: downs008@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00903630     History of Changes
Other Study ID Numbers: 2008LS047
0805M32463 ( Other Identifier: IRB, University of Minnesota )
WCC #50 ( Other Identifier: Women's Cancer Center, University of Minnesota )
RV-OVAR-PI-0447 ( Other Identifier: Celgene Corporation )
First Submitted: May 15, 2009
First Posted: May 18, 2009
Results First Submitted: April 22, 2015
Results First Posted: January 18, 2017
Last Update Posted: December 28, 2017