Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)
|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
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Leiomyosarcoma Malignant Peripheral Nerve Sheath Tumor Malignant Fibrous Histiocytoma/Undifferentiated Pleomorphic Sarcoma||Drug: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IB/II Study of Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)|
|Study Start Date :||August 2011|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
Experimental: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination
This will be a multicenter single arm phase IB/II trial to evaluate the clinical safety and efficacy of gemcitabine/docetaxel and pazopanib in the neoadjuvant treatment of soft tissue sarcoma.
Drug: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination
Patients who meet the eligibility criteria above will be treated with the combination therapy of Gemcitabine, Docetaxel, and Pazopanib for two cycles and subsequently re-evaluated for treatment effect. If no progression of the tumor is seen, patients will continue with two more cycles of treatment (total four cycles). Those patients who have progression of disease will proceed directly to surgical resection.
Following completion of neoadjuvant treatment, all patients will have definitive surgical resection. Following recovery from surgery, patients will proceed with adjuvant radiation therapy. Patients will then be followed for 2 years or until January 1st 2015, whichever comes first .
- Overall Objective Response [ Time Frame: Every 6 weeks up to 2 years ]
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.
- Pathologic Response [ Time Frame: 2 years ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418001
|United States, California|
|Los Angeles, California, United States, 90095|
|United States, Illinois|
|Evanston, Illinois, United States, 60208|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||William Tap, MD||Memorial Sloan Kettering Cancer Center|