MDACC Study Summary ID03-0009

Study Summary
No. ID03-0009:.......Pancreas......Razelle Kurzrock......Experimental Therapeutics

Study Summary Title



Study Summary Number:	ID03-0009

Study Title:	Phase II Trial of Curcumin in Patients with Advanced Pancreatic Cancer

Physician

New Patient Referral



Name:	Razelle Kurzrock	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Experimental Therapeutics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-1226 Contact us about clinical trials

General Information



Disease Group:	Pancreas	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Participants must come to MDACC about once every two months.

Treatment Agents:	Curcumin	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if treatment with curcumin can help shrink or slow the growth of pancreatic cancers. The effect of curcumin on the way pancreatic cancer cells function and the safety of treatment with curcumin will also be studied.

Study Objectives / Outcomes

The objectives of the trial will be to:
(I) Evaluate six month survival and response rates.
(II) Evaluate side effects of curcumin in patients with pancreatic cancer.
(III) Assess pharmacokinetics of curcumin after oral administration in this population.
(IV) Assess biologic activity of this molecule in both tumor and surrogate tissues (peripheral blood mononuclear cells) including baseline and post-therapy effects on signaling and apoptosis.
(V) Longitudinally assess patient symptom burden (prevalence, severity, patterns of symptoms) over the course of the trial.

Study Status Information



Study Activation / Registration Date:	11/12/2004

IRB Review and Approval Date:	08/06/2003

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) The patient has pathologically confirmed adenocarcinoma of the pancreas that is not amenable to curative surgical resection (includes locally advanced, metastatic, or recurrent disease). Histology must be confirmed by the pathology department of the investigational center.

2) The patient has a Karnofsky Performance Status of greater than or equal to 60 at study entry.

3) The patient has given informed consent.

4) The patient is at least 18 years of age.

5) The patient has adequate hematologic function as defined by an absolute neutrophil count greater than or equal to 1,500/mm3, platelet count greater than or equal to 100,000/mm3.

6) The patient has adequate hepatic function as defined by a total bilirubin less than or equal to 2.0 X ULN, alkaline phosphatase, AST and/or ALT less than or equal to 5 X ULN, and creatinine less than or equal to 2.0 mg/dL.

7) The patient has measurable disease.

8) The patient agrees to use effective contraception if procreative potential exists.

Exclusion Criteria:

1) The patient has a history of treated or active brain metastases, carcinomatous meningitis, an uncontrolled seizure disorder, or active neurological disease.

2) The patient has received prior radiation. Patients with measurable disease outside the radiation port or documented disease progression of previously irradiated measurable disease are eligible. Patient must be greater than or equal to four weeks post-therapy and have recovered from all toxicities.

3) The patient has an unstable medical condition according to the investigator, including uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals, unstable CHF, uncontrolled arrythmias, or unstable coagulation disorders.

4) The patient is pregnant (confirmed by serum Beta-HCG) or is breast feeding.

5) The patient has received an investigational agent(s) within four weeks of study entry.

Links

Registration Number: NCT00094445
Study Information on Clinical Trials Registry (clinicaltrials.gov)