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Trial record 6 of 66 for:    Soft Tissue | "Dermatofibroma"

Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)

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ClinicalTrials.gov Identifier: NCT01418001
Recruitment Status : Terminated (Lack of accrual)
First Posted : August 16, 2011
Results First Posted : February 17, 2016
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
National Comprehensive Cancer Network
University of California, Los Angeles
Washington University School of Medicine
Northwestern University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sarcoma
Leiomyosarcoma
Malignant Peripheral Nerve Sheath Tumor
Malignant Fibrous
Histiocytoma/Undifferentiated Pleomorphic Sarcoma
Intervention Drug: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination
Enrollment 5

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pazopanib 400 mg QD
Hide Arm/Group Description Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Level 1: Pazopanib 400 mg QD Gemcitabine and Docetaxel in Com
Hide Arm/Group Description Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  20.0%
>=65 years
4
  80.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
1.Primary Outcome
Title Overall Objective Response
Hide Description

Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

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

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Time Frame Every 6 weeks up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Level 1: Pazopanib 400 mg QD
Hide Arm/Group Description:
Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 3
Stable Disease (SD) 2
2.Secondary Outcome
Title Pathologic Response
Hide Description will be assessed by both MRI and by pathologic review after surgery. An estimate of each response rate and the 95% CI will be provided
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data is available because data was not collected due to lack of accrual.
Arm/Group Title Pazopanib 400 mg QD
Hide Arm/Group Description:
Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Level 1: Pazopanib 400 mg QD
Hide Arm/Group Description Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
All-Cause Mortality
Level 1: Pazopanib 400 mg QD
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Level 1: Pazopanib 400 mg QD
Affected / at Risk (%)
Total   3/5 (60.00%) 
Blood and lymphatic system disorders   
Alanine aminotransferase increased  1  1/5 (20.00%) 
General disorders   
Fatigue  1  1/5 (20.00%) 
Infections and infestations   
Wound infection  1  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Level 1: Pazopanib 400 mg QD
Affected / at Risk (%)
Total   5/5 (100.00%) 
Blood and lymphatic system disorders   
Alanine aminotransferase increased  1  2/5 (40.00%) 
Anemia  1  4/5 (80.00%) 
Aspartate aminotransferase increased  1  1/5 (20.00%) 
Lymphocyte count decreased  1  2/5 (40.00%) 
Platelet count decreased  1  1/5 (20.00%) 
Cardiac disorders   
Hypertension  1  1/5 (20.00%) 
Gastrointestinal disorders   
Diarrhea  1  1/5 (20.00%) 
Nausea  1  1/5 (20.00%) 
General disorders   
Fatigue  1  2/5 (40.00%) 
Hoarseness  1  1/5 (20.00%) 
Mucositis oral  1  1/5 (20.00%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  2/5 (40.00%) 
Hypertriglyceridemia  1  2/5 (40.00%) 
Hypoalbuminemia  1  2/5 (40.00%) 
Hypocalcemia  1  2/5 (40.00%) 
Hyponatremia  1  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. William Tap
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4163
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01418001     History of Changes
Other Study ID Numbers: 11-104
First Submitted: August 15, 2011
First Posted: August 16, 2011
Results First Submitted: January 19, 2016
Results First Posted: February 17, 2016
Last Update Posted: January 11, 2018