A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with MORAb-004 in Metastatic Soft Tissue Sarcoma
To evaluate the progression-free survival of patients treated with the combination of gemcitabine/docetaxel (G/D) plus MORAb-004 versus G/D plus placebo in patients with metastatic soft tissue sarcoma. To assess overall survival, overall response rate, and progression free survival. To assess safety and tolerability of MORAb-004 in combination with gemcitabine and docetaxel. To correlate the patter or biomarker expression in tumor samples and plasma. This is a multicenter, 2-part, Phase 2 study. Johns Hopkins will be participating in the Phase 2 portion of the study.
Patients must be at least 18 years of age. Patients with the following histologically confirmed diagnosis of the following sub-type of sarcoma are eligible: Liposarcoma (excluding pure, well-differentiated sarcoma), Leiomyosarcoma, Undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (UPS previously characterized as MFH), Other STS, i.e., patients with a histologic diagnosis of high grade sarcoma not otherwise specified (NOS), angiosarcoma, synovial sarcoma, rhabdomyosarcoma, hemagiopericytoma/solitary fibrous tumor, or other liposarcoma. Patient must have received 0-2 prior regimens of systemic treatment for soft tissue sarcoma (prior treatment with an anthracycline-based regimen is allowable but not required). An interval between prior cancer treatment and first infusion of study related treatment must be at least 2 weeks. Patient must have measurable disease. Patient must have good organ function with good blood counts and be up and out of bed at least 75% of the day (or more). Patient must be willing to submit tumor tissue from prior biopsy/surgery. Patients with a medical condition with a high risk of bleeding or with a recent (within the past 6 months) history of a significant bleeding event will be excluded. Patients with active viral hepatitis or symptomatic HIV infection will be excluded (asymptomatic positive serology is not exclusionary). Patients who have a history of allergic reaction to prior monoclonal antibody or biologic agent will be excluded.
Part 2 of the study will be a randomized, double-blind, and placebo-controlled study of the maximum recommended dose (established in Part 1) in combination with full-dose Gemcitabine and Docetaxel VERSUS placebo in combination with full-dose Gemcitabine/Docetaxel. Treatment will be administered on Days 1, 8 of each 21-day cycle. After review of consent form and screening tests to determine the patient is eligible, patient will be enrolled onto the study and randomized. Treatment will be administered in the outpatient clinic. Patients will receive Gemcitabine on Days 1 and 8 of each cycle and Docetaxel on Day 8 of each 21-day cycle. MORAb-004 (study drug) or placebo will be administered on Days 1 and 8 of each 21-day cycle. Patient will be required to come to clinic, at least weekly, for blood work/urine tests, doctor/nurse visits, CT Scans or MRIs and other applicable tests and procedures to ensure safety and tolerability of this study regimen. There are additional research blood tests that will be required, while others are optional. Your study team will review this, in detail, with you prior to consenting. These additional research blood tests may require extra visits to the clinic and/or longer stays at the clinic on certain days. Treatment will continue as long as the patient is tolerating it and it is deemed safe to continue by the study doctor. Adherence to all protocol tests/procedures and visits is required to ensure the patient can be monitored closely and to ensure safety while participating.
05/21/2013 04:02 AM