MDACC Study Summary 2006-0644

Study Summary
No. 2006-0644:.......Rectum......Sunil Krishnan......Radiation Oncology

Study Summary Title



Study Summary Number:	2006-0644

Study Title:	A Randomized Double Blinded Study of Curcumin with Pre-operative Capecitabine and Radiation Therapy Followed by Surgery for Rectal Cancer

Physician

New Patient Referral



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

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

Phone:	713-563-2361 Contact us about clinical trials

General Information



Disease Group:	Rectum	Supported By:	Gateway for Cancer Research

Phase of Study:	Phase II	Return Visit:	Once a day, five days in a row for 5-6 weeks, then once after 6-12 weeks. One month after surgery, every 3 months for the first 3 years, and every 6 months after that.

Treatment Agents:	Curcumin	Home Care:	n/a

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to learn if combining a curcumin preparation with standard radiation therapy and chemotherapy (capecitabine) can help to shrink or slow the growth of rectal cancer. The safety of this combination and whether curcumin can help to decrease some of the side effects of standard radiotherapy and chemotherapy will also be studied.

Study Objectives / Outcomes

The primary objective of this study is to evaluate the efficacy of a combination of capecitabine and radiation therapy with or without curcumin in locally advanced rectal cancer as assessed by pathological complete response rate.

Secondary objectives include:
- To determine downstaging, local control, disease-free survival and overall survival rates.
- To determine serum and rectal tumor tissue pharmacology of curcumin and its metabolites in the above patients and its correlation with clinical response.
- To identify surrogate molecular markers for curcumin effects.
- To correlate serum cytokine levels with quality of life in patients receiving this therapy.

Study Status Information



Study Activation / Registration Date:	08/11/2008

IRB Review and Approval Date:	12/19/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	45

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) All patients must have clinical stage T3,4 N0,1,2 or T2N1,2 adenocarcinoma of the rectum. Patients will be clinically staged using endorectal ultrasound, pelvic CT, and physical examination.

2) Histology must be confirmed with review by the Department of Pathology at MDACC.

3) All patients must have no distant metastatic disease in the liver, peritoneum, lungs, or paraaortic lymph nodes.

4) Patients must have a performance status (Karnofsky scale) of 70% or greater.

5) Patient must be >/= 18 years of age.

6) Patients must have ANC > 1500 cells/mm^3, platelets > 100,000/mm^3, total serum bilirubin < 2 mg/dl, BUN <30 mg/dl, creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min (estimated as calculated with Cockcroft-Gault equation). Creatinine Clearance (men) = {(140 - age) x lean body weight (in kg.)}/ {Plasma creatinine (mg/dl) x 72} Creatinine Clearance (women) = 0.85 x {(140 - age) x lean body weight (in kg.)}/ {Plasma creatinine (mg/dl) x 72}

7) Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary. Patients must also agree to refrain from use of additional herbal supplements during the course of the study.

8) Patients will agree to continue contraception for 30 days from the date of the last study drug administration. Sexually active males must practice contraception during the study.

9) Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria:

1) Prior radiotherapy to the pelvis.

2) Pregnant or lactating woman. Women of childbearing potential who have not undergone a hysterectomy with either a positive or no pregnancy test at baseline. Women / men of childbearing potential not using a reliable and appropriate contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).

3) Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.

4) Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or requiring IV antibiotics, cardiac disease NYHA class III or IV, unstable angina pectoris, unstable cardiac arrythmia or tachycardia (heart rate > 100 beats/minute), or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.

5) Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.

6) Major surgery within 4 weeks of the start of study treatment.

7) Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5–fluorouracil or capecitabine or curcumin.

8) Concurrent use of coumadin other than low dose (1 mg) coumadin used for line patency. Patients on coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine.

9) Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox.

10) Sorivudine and brivudine use within 4 weeks of the start of study treatment.

Links

Registration Number: NCT00745134
Study Information on Clinical Trials Registry (clinicaltrials.gov)