A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
|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: NCT01593748|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: Gemcitabine and Pazopanib Drug: Gemcitabine and Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) With Pazopanib (P) or Gemcitabine (G) With Docetaxel (T) in Previously Treated Subjects With Advanced Soft Tissue Sarcoma|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||April 2, 2019|
|Estimated Study Completion Date :||April 2, 2019|
Experimental: Group 1
Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal.
Drug: Gemcitabine and Pazopanib
Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Pazopanib 800 mg by oral tablet daily for a 21 day cycle.
Active Comparator: Group 2
Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1).
Drug: Gemcitabine and Docetaxel
Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle.
- Progression-free survival [ Time Frame: 18 months ]To estimate the progression-free survival (PFS) of the combination of gemcitabine plus pazopanib (G+P) and to estimate the PFS of the combination of gemcitabine plus docetaxel (G+T) in patients with previously treated, metastatic and/or locally advanced or recurrent soft tissue sarcoma. To estimate the rate of grade 3 or higher toxicity with G+P and G+T and to describe the type and grade of toxicities.
- Hazard ratio [ Time Frame: 18 months ]To estimate the hazard ratio comparing G+P vs. G+T in patients with previously treated, metastatic and/or locally advanced or recurrent soft tissue sarcoma. To estimate the response rates of G+P and G+T in metastatic and/or locally advanced or recurrent soft tissue sarcoma patients. To examine quality of life (QOL) measures with both regimens (using EORTC QLQ-C30 version 3 and EuroQol questionnaires).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593748
|United States, Arizona|
|The University of Arizona Cancer Center|
|Tucson, Arizona, United States|
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Iowa|
|University of Iowa Hospitals & Clinics|
|Iowa City, Iowa, United States|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21218|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Washington University at St. Louis|
|Saint Louis, Missouri, United States, 63130|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Daniel Y. Reuben, MD||Medical University of South Carolina Hollings Cancer Center|