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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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)

Brief Summary: The purpose of this study is to see the effects, good and/or bad, of the drug combination of gemcitabine, docetaxel and pazopanib on sarcoma. This is a phase Ib-phase II clinical trial. The goal of a phase Ib part of the clinical trial is to confirm a dose of the drugs that is safe. The investigators determine this by closely checking for side effects that the patient may experience.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: Overall Objective Response [ Time Frame: Every 6 weeks ]

Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.


Original Primary Outcome:

  • maximum tolerated dose (MTD) [ Time Frame: 2 years ]
    standard 3+3 format
  • To assess the effectiveness of in improving distant relapse free survival (DRFS) [ Time Frame: 2 years ]


Current Secondary Outcome: 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


Original Secondary Outcome:

  • 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
  • time to distant recurrence [ Time Frame: 2 years ]
  • time to local recurrence [ Time Frame: 2 years ]
  • pathologic response to the combination therapy based in post-treatment specimen [ Time Frame: 2 years ]
    Histologic response to the combination of pazopanib /gemcitabine/docetaxel will be assessed as a percentage and will be graded, based on the gross and microscopic amounts of necrosis and fibrosis, using a previously proposed grading scheme47: 1, minimal (0-10% response); 2, low (>10% and ≤50% response); 3, moderate (>50% and ≤90% response); and 4, high (>90% response). Other histologic variables, including the type of tumor (spindle/epithelioid) and mitotic count (per 50 high-power fields), were recorded.


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: August 15, 2011
Date Started: August 2011
Date Completion:
Last Updated: January 19, 2016
Last Verified: January 2016