Clinical Trials

The following clinical cancer protocols are offered through the Norris Comprehensive Cancer Center:

Protocol 3P-01-1

Principal Investigator: Agustin Garcia, M.D.

Description:
Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination with Gemcitabine versus Placebo in Combination with Gemcitabine in Previously Untreated Subjects with Locally Advanced (Non-Resectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas.

Status: Open
Randomized: Yes
Patient Accrual Goal: 130

Eligibility Requirements

Pro Eligibility Requirements:

• Histological or cytological confirmation of pancreatic adenocarcinoma who are not suitable for pancreatic tumor resection with curative intent.
• Measurable and/or evaluable disease.
• Male or female patients, 18 years and older.
• Life expectancy of at least 3 months.
• Karnofsky performance status at least 70%.
• WBC = / >3.0; platelets = / >100,000; Hgb = / >9.5.
• Total bilirubin < / = 1.5; SGOT and SGPT < / = 2.5 x uln (SGOT and SGPT < / = 5 x uln if with liver involvement).
• Creatinine < / = 1.5.
• Contraceptive measures for sexually active patients.
• Signed informed consents.

Con Eligibility Requirements:

• History of other malignant disease, except non-melanomatous skin carcinoma or in-situ carcinoma of the cervix.
• Prior chemotherapy, RT, or immunotherapy.
• Patients taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or during the study.
• Concomitant use or anticipated use of curative RT for the period of the study.
• Concomitant use or anticipated use of chemotherapeutic agents other than gemcitabine for the period of the study.
• Requires chronic administration of corticosteroids, except inhaled corticosteroids for asthma or COPD.
• Use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids.
• Immunodeficiency (primary [genetic] or acquired [AIDS]).
• Underwent BMT within the last year.
• Previously known or documented brain metastases.
• Suffering from any other severe condition as defined by the following: unstable cardiac disease despite treatment, MI within 6 months prior to study entry, history of significant neurologic or psychiatric disorders including dementia or seizures, active uncontrolled infection, active DIC, or any other serious underlying medical conditions which could impair the ability of the subject to participate in the study.
• Pregnant or lactating females.
• Patients clearly intending to withdraw from the study if not enrolled in a given arm, or patients who cannot be regularly followed up for psychological, social, familial, or geographic reasons.

Protocol RTOG-9704

Principal Investigator: Oscar Streeter, M.D.

Description:
A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Post-Operative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma.

Status: Open
Randomized: Yes
Patient Accrual Goal: 330

Eligibility Requirements:

Pro Eligibility Requirements

• Histologic proof of adenocarcinoma of pancreas (primary tumor of pancreas, i.e., pancreatic head, neck, uncinate process, body, or tail) (AJCC pathologic stage T1-3 N0-1).
• Patient has undergone a potentially curative resection, i.e., removal of all gross tumor.
• The maximum diameter/dimension of the primary tumor, as obtained from pathologic specimen, and the tumor status at surgical margin (i.e., negative, positive, or unknown) must be known at registration.
• Post-resectional CA 19-9 level. (If level <2u/ml, blood typing for Lewis antigen must be done).
• At least 18 years of age.
• Karnofsky performance status at least 60%.
• WBC = / >3.0; platelets = / >100,000.
• Bilirubin and creatinine < / = 1.5 x uln; SGOT < / = 5 x uln.
• Before starting therapy, patient should be able to maintain adequate oral nutrition, e.g., at least 1500 calories estimated caloric intake/day, and free of significant nausea and vomiting. If necessary, a feeding tube should be used to maintain caloric intake >1500 calories daily.
• Registration must be between day 21 and day 41 after definitive tumor-related surgery. Protocol treatment must begin within 3-6 weeks (21-42 days) after definitive tumor-related surgery and within 5 business days after randomization.
• Signed informed consent, to include a section on the possibility of need for deep line access, i.e., PICC, Groshong, Hickman or Port.

Con Eligibility Requirements

• Non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinoma, cystadenomas, cystadenocarcinoma, carcinoid tumors, duodenal carcinoma, distal bile duct or ampullary carcinoma.
• Stage M1 or Nx tumor.
• Patients in whom regional lymph nodes cannot be identified for pathologic review.
• Pregnancy. Men and women of reproductive potential must agree to use an effective contraceptive method.
• Patients with recurrent disease.
• Prior chemotherapy or RT.
• Previous history of active malignancy within 5 years prior to study entry, except in-situ cervical cancer or non-melanoma skin cancer.

Protocol 3P-01-3

Principal Investigator: Heinz Josef Lenz, M.D.

Description:
A Randomized Placebo-Controlled Study of OSI-774 (Tarceva) Plus Gemcitabine in Patients with Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer.

Status: Open
Randomized: No

Eligibility Requirements: