USC/Norris Comprehensive Cancer Center
USC/Norris
About USC/Norris
Patient Care
Research
Clinical Trials
Search Trials
Faculty
Education
Future at USC/Norris
Core Facilities
Support USC/Norris
» Contact Us
» Glossary
» Make a Donation
If you are a patient, please contact
The Doctors of USC
at 800-USC-CARE.
Details for trial 3G-07-1
Description:
A Randomized Phase II Study of Patients with Locally Advanced Gastric or Gastro-Esophageal Adenocarcinoma Treated with Induction Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Adjuvant Intraperitoneal Floxuridine Followed By Prolonged Administration of Capecitabine.
Status:
Open
Randomized?
Yes
Researchers
Principal Investigator
Title
Syma Iqbal
M.D.
Data Management
Name
Title
Ramona Lujan
R.N.
Noureddine Miloud
D.M.
Yordy Brito
D.M.
You may participate in this study if:
Requirement
1
Untreated patients with histologically documented gastric/GEJ adenoca, clinical AJCC stage grouping (11) IB-IV (Mo) by CT Scan & laparoscopic/endoscopic ultrasound. Ineligible if in need of urgent surgery for gastrointestinal obstruction, perforation or hemorrhage.
2
18 years old and above.
3
ECOG 0-2.
4
ANC 1500 and above; Platelets 100,000 and above; hemoglobin 9.0 and above.
5
Total serum bilirubin 2.0 or less; SGOT/SGPT less than or equal to 2x upper limit of normal; Alkaline Phoshatase less than or equal to 3x upper limit of normal.
6
BUN 30 or less; Serum creatinine 1.5 or less; Creatinine Clearance 50 mL/min or more; Creatinine Clearance should be normalized for 1.73m2 BSA.
7
PT, aPTT & thrombin time within normal.
8
Women must not be pregnant or breast-feeding.
9
All women of childbearing potential must have negative serum or urine pregnancy test within 2 weeks prior to registration.
10
All patients of reproductive age must agree to use an effective medically acceptable contraceptive method.
11
Signed Informed Consent, including HIPAA authorization.
You may not participate in this study if:
1
Other invasive malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or if patient has been disease-free of cervical carcinoma in situ or other in-situ cancer for 5 years or more.
2
Active or uncontrolled infection including HIV.
3
Psychiatric disorders that may interfere with consent &/or protocol follow-up.
4
Patients with Gilbert's disease & bilirubin 2.0 mg/dL or greater, as they may have excessive CPT-11 toxicity.
5
No prior severe reaction to fluoropyrimidine treatment or known hypersensitivity to 5-FU.
6
Any severe concurrent disease, such as cardiac condition not responding to medication, MI within last 12 mos, active infection or uncontrolled pulmonary disease, or any other disease which would make patient inappropriate for study.
For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.
