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
-To estimate the progression-free survival of the combination of gemcitabine plus pazopanib and to estimate the progression-free survival of the combination of gemcitabine plus docetaxel in patients with previously treated, metastatic and/or locally advanced or recurrent soft tissue sarcoma. -To understand how well patients can tolerate the side effects of gemcitabine plus pazopanib versus gemcitabine plus docetaxel and to learn if one treatment arm has worse side effects than the other. -To examine quality of life measures of patients on both treatment arms.
Patients must be at least 18 years of age with histologically or cytologically confirmed diagnosis of metastatic and/or locally advanced or locally recurrent sarcoma of soft tissue (liposarcoma, bone sarcoma, and GIST will be excluded). Patientâ??s disease must be measurable by CT Scan or MRI. Patient must be up and out of bed/active for at least 50% of the day. Patient must have good blood counts and good organ function. Patient must have had a minimum of 1 and a maximum of 3 prior chemotherapy regimens for recurrent/metastatic disease. Patients eligible for an anthracycline (doxorubicin/adriamycin/doxil) should have received a prior anthracycline containing regimen. Patient must be able to swallow oral medication. Patients who have received prior therapy with pazopanib, gemcitabine, or docetaxel will be excluded. Patient may not have history or clinical evidence of CNS metastaese. Previously treated CNS metastases is allowed if patient is asymptomatic and has had no requirement for steroids or anti-seizure medication for 6 months prior to the first dose of study drug. Patients with active peptic ulcer disease, ulcerative colitis, Crohnâ??s disease will be excluded. patients with history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months will be excluded (Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
Patients will be randomized (like the flip of a coin) to receive either Gemcitabine plus Pazopanib (G+P) or Gemcitabine plus Docetaxel (G+T). Those on G+P will receive Gemcitabine 1000mg/m2 IV over 90 minutes on Days 1 and 8 of every 21 day cycle along with Pazopanib 800mg by mouth once daily on days 1 through 21. Patients randomized to receive G+P will be required to maintain a drug diary to track self-administration of Pazopanib. Those randomized to G+T will receive Gemcitabine 900mg/m2 IV over 90 minutes on Days 1 and 8 along with Docetaxel 100mg/m2 IV over 60 minutes on Day 8 of every 21 day cycle. Patients will receive their applicable treatment every 21 days until disease progression and/or intolerable side effects. This treatment is administered in the clinic on an outpatient basis. CT Scans and/or MRIs will be performed every 2 cycles to determine response. Frequent visits with doctor, study nurse will be required along with tests and procedures to monitor safety (blood tests, EKGs) while on this study. Adherence to all study required visits and care is required to ensure the safety of patients participating on this trial.
11/25/2014 04:06 AM