A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
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
3 other identifiers
interventional
90
1 country
8
Brief Summary
This study is for adult subjects with advanced tissue sarcoma. The study involves the drugs Pazopanib (Votrient), Gemcitabine (Gemzar), and Docetaxel (Taxotere). The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2012
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedStudy Start
First participant enrolled
September 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2019
CompletedResults Posted
Study results publicly available
April 6, 2020
CompletedApril 6, 2020
March 1, 2020
6.6 years
May 4, 2012
March 23, 2020
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Average Number of Months of Progression-free Survival
To estimate the PFS of the combination of G+P or G+T in patients with metastatic and/or locally advanced or recurrent STS. Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
minimum of 18 months
Rate of Participants With Grade 3 or Higher Toxicity
Toxicity is graded according to the CTCAE v 4.
30 days post end of treatment
Secondary Outcomes (3)
Hazard Ratio
minimum of 18 months
Average Score of Quality of Life
Baseline, Cycle 2, Cycle 6 and End of Treatment
Response Rate
minimum of 18 months
Study Arms (2)
Experimental
EXPERIMENTALPatients 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.
Standard of Care
ACTIVE COMPARATORPatients 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).
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- Prior therapy with pazopanib, gemcitabine or docetaxel.
- Any concern for hypersensitivity to pazopanib, gemcitabine or docetaxel.
- Prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases.
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- Active peptic ulcer disease
- Known intraluminal metastatic lesion/s with risk of bleeding
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- Malabsorption syndrome
- Major resection of the stomach or small bowel and experiencing the "dumping" syndrome.
- Presence of uncontrolled infection.
- Prior mediastinal radiation
- Corrected QT interval (QTc) \> 480 msecs using Bazett's formula.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of South Carolinalead
- Novartiscollaborator
Study Sites (8)
The University of Arizona Cancer Center
Tucson, Arizona, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University at St. Louis
St Louis, Missouri, 63130, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Xin G, Wang M, Jiao LL, Xu GB, Wang HY. Protein-to-creatinine ratio in spot urine samples as a predictor of quantitation of proteinuria. Clin Chim Acta. 2004 Dec;350(1-2):35-9. doi: 10.1016/j.cccn.2004.06.019.
PMID: 15530457BACKGROUNDNational Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PMID: 11904577BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cameron Coggins
- Organization
- MUSC
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Y. Reuben, MD
Medical University of South Carolina Hollings Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2012
First Posted
May 8, 2012
Study Start
September 27, 2012
Primary Completion
April 24, 2019
Study Completion
April 24, 2019
Last Updated
April 6, 2020
Results First Posted
April 6, 2020
Record last verified: 2020-03