ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer
People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body).
The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer.
ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
Metastatic Pancreatic Cancer
Drug: ABT-888 and mFOLFOX-6
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of ABT-888 in Combination With 5-fluorouracil and Oxaliplatin (Modified FOLFOX-6) in Patients With Metastatic Pancreatic Cancer|
- Dose limiting toxicities [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Adverse events will be graded according to NCICTAE version 4
- Objective Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]Complete response + Partial response
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: ABT-888 and mFOLFOX-6
ABT-888 orally at escalating does in Phase I and then at recommended phase II dose with standard mFOLFOX-6
Drug: ABT-888 and mFOLFOX-6
ABT-888 in escalating doses twice a day for Days 1-7 of each 14-day cycle Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
This is a single arm, open-label Phase I/II study to evaluate the clinical activity of the novel inhibitor of Poly(ADP-ribose) polymerase (PARP), ABT-888 with modified FOLFOX-6 (5-Fluorouracil plus oxaliplatin) in patients with metastatic pancreatic cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489865
|Contact: Lisa Ley, RN MSN||202-687-6653||Leyl@georgetown.edu|
|Contact: Karen Dorsch-Vogel, RNfirstname.lastname@example.org|
|United States, District of Columbia|
|Georgetown Lombardi Comprehensive Cancer Center||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Lisa Ley, RN MSN 202-687-6653 email@example.com|
|Contact: Karen Dorsch-Vogel, RN 202-687-6974 firstname.lastname@example.org|
|Principal Investigator: Michael Pishvaian, MD PhD|
|Principal Investigator:||Michael Pishvaian, MD PhD||Georgetown University|