A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine, in subjects with metastatic pancreatic cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer|
- Survival [ Time Frame: 7 Months ] [ Designated as safety issue: No ]
- Tumor Response [ Time Frame: 8 weeks assessment and 16 weeks to confirm ] [ Designated as safety issue: No ]
- Toxicity and Safety Parameters [ Time Frame: Continuously ] [ Designated as safety issue: Yes ]
- Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers [ Time Frame: Every 14 Days and Study Completion ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||August 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: gemcitabine and RX-0201
Gemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off.
RX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off.
Drug: RX-0201 plus Gemcitabine
RX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off. Gemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off.
Subjects enrolled to assess safety will receive a combination of Gemcitabine plus RX-0201. Gemcitabine will be administered prior to RX-0201 intravenously in a 30-min iv infusion dose at 1000 mg/m2 once weekly for up to 2 cycles; each 4-week cycle consist of 3-week treatment phase followed by 1 week resting phase. RX-0201 will be administered at 250 mg/m2/day in a 24-hour continuous intravenous infusion for up to 2 cycles; each 3-week cycle consists of 2-week treatment phase followed by a 1 week resting phase. (See schedule of assessments)Subjects enrolled to evaluate efficacy will receive a combination of Gemcitabine and RX-0201 as outline above for up to 4 cycles.
|United States, Florida|
|Baptist Cancer Institute|
|Jacksonville, Florida, United States, 32207|
|United States, Illinois|
|Orchard Healthcare Research Inc.|
|Skokie, Illinois, United States, 60077|
|United States, Texas|
|Austin, Texas, United States, 78705|
|Texas Oncology, P.A.|
|McAllen, Texas, United States, 78705|
|Jawaharlal Nehru Cancer Hospital and Research Centre|
|Bhopal, Kerala, India, 462 001|
|Meenakshi Mission Hospital and Research Center|
|Central India Cancer Research Institute|
|Shatabdi Superspeciality Hospital|
|Rajiv Gandhi Cancer Institute and Research Center|
|Rohini New- Delhi, India|
|King George Hospital|
|Visakhapatanam, A.P, India|
|Study Chair:||Margaret Tempero, M.D|