AZD2281 and Cisplatin Plus Gemcitabine to Treat Solid Tumor Cancers

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00678132

Run by

National Cancer Institute (NCI)

People needed

23

Starts

2008-04-24

Expected to finish

2010-11-23

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or those who have not recovered from AEs due to agents administered more than 4 weeks earlier. Patients must be greater than or equal to 2 weeks since any investigational agent was administered as part of an exploratory IND study and should have recovered to eligibility levels from any toxicity.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, prolonged QTc interval (greater than 500 msec), or psychiatric illness/social situations that would limit compliance with study requirements.
• In the Food and Drug Administration (FDA) Use-in-Pregnancy Ratings for Drugs, cisplatin and gemcitabine are classified as category D drugs, indicating that investigational or postmarketing data show risk to the fetus. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after completion of study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is a risk for AEs in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued while the patient is on this trial and for 30 days after completion of treatment on this trial.
• Patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status remains stable for greater than or equal to 1 month after treatment of the brain metastases without steroids (except for maintenance replacement doses of steroids) or anti-seizure medications.
• Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies or confirmed diagnosis of HIV infection, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are excluded from this trial.
• Patients with lymphomas and primary CNS malignancies are excluded from this study.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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