A Phase I Combination Study of AZD2281 and Cisplatin Plus Gemcitabine in Adults With Solid Tumors

Background:

• AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage; PARP inhibitors interfere with that process.
• Cisplatin and gemcitabine are approved by the United States Food and Drug Administration to treat certain cancers.

Objectives:

• To determine the optimum doses of AZD2281, cisplatin and gemcitabine in combination that can safely be given to patients with solid tumor cancers.
• To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment.

Eligibility:

-Patients 18 years or older with an advanced solid tumor cancer for whom standard treatments are not effective.

Design:

• In this dose escalation study, the first small group of patients receives the smallest study doses of the study drugs. Subsequent groups receive incrementally higher doses as long as the preceding group does not experience unacceptable side effects. When the highest safe dose is determined, additional patients entering the study receive that dose.
• Patients receive treatment in 21-day cycles as follows:
• Days 1-4: AZD2281 by mouth twice a day
• Day 3: gemcitabine thorough a vein over 1 hour; then cisplatin through a vein over 1 hour.
• Day 10: gemcitabine through a vein over 1 hour.
• Evaluations during treatment include the following:
• Physical examination, vital signs check and blood tests every 3 weeks.
• CT scans every 6 weeks to evaluate the tumor.
• Treatment may continue until it is no longer beneficial.