Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:August 2008

Use our guide to learn which trials are right for you!

A Randomized Dose Escalation, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer

Gemcitabine is usually used to treat cancer of the pancreas. The purpose of this study is to
determine if Kanglaite Injection (KLT) is safe in patients with cancer of the pancreas, and
whether it improves the effectiveness of gemcitabine. Additionally, the effect, if any, of
KLT on the signs and symptoms of cancer as well as the common side effects of chemotherapy
will be evaluated.

The research drug, KLT, is purified from a traditional Chinese medicine called coix seed.
It is approved in China for use in combination with chemotherapy to treat patients with
advanced lung cancer and liver cancer. It is also approved in China for use by itself to
treat the symptoms of cancer in patients with advanced cancer of any kind. In the US, KLT
is purely experimental and is not approved for any use. While a small number of cancer
patients in the US have received KLT alone in a Phase I study, this is the first US protocol
to evaluate whether or not KLT is useful in pancreatic cancer.


Inclusion Criteria:

- Must have a life expectancy of at least 84 days (12 weeks)

- Must be ambulatory and have either a Karnofsky performance status of 60 or higher or
ECOG performance status of 0, 1 or 2

- Must have histologically confirmed pancreatic cancer, either locally invasive or
metastatic, and not amenable to potentially curative resection

- Must have measurable or evaluable target lesions, by RECIST criteria

- Must not have previously received chemotherapy for metastatic disease

- If female, must have negative pregnancy test, be at least one year post menopausal,
or have undergone surgical sterilization and must be willing to use appropriate birth
control measures unless post menopausal or post surgical sterilization

- Must be judged by the Investigator to have the initiative and means to be compliant
with the protocol including the return for follow-up visits on schedule

- Must give written informed consent prior to any testing under this protocol

- Must have Hemoglobin > 9 gm/dl, WBC>2 x109/ml, and platelets >100,000/ul

- Must have Alkaline Phosphatase < 2.5 x ULN, ALT < 2.0 x ULN, AST< 2.0 x ULN and
bilirubin < 2.0

- Must have stable renal function appropriate for age. A patient must have a serum
creatinine of < 1.5mg/dl or a GFR > 60 mL/minute

- Must have a central venous catheter

Exclusion Criteria:

- Patient has a history of cancer within 5 years other than pancreatic cancer
(excluding resected non melanoma skin carcinoma

- Patient has active (untreated or still receiving corticosteroids) brain metastases

- Patient has had prior chemotherapy for metastatic disease

- Patient has received prior gemcitabine < 12 months previously

- Patient is currently taking a bile acid sequestrant drug (such as Questran, Colestid
or Welchol) or a fibric acid derivative drug (such as Lopid, Tricor, Antara, Lofibra
and Trilipix) - Patients with disturbances of lipid metabolism such as pathologic
hyperlipidemia (including congenital hypertriglyceridemia or cholesterolemia), lipoid
nephrosis, or acute pancreatitis

- Patient has uncontrolled Type 1 or 2 diabetes mellitus

- Patient has another active medical condition(s) or organ disease(s) that may either
compromise patient safety or interfere with the safety and/or outcome (e.g.,
survival) evaluation of the study drugs

- Patient or physician plans surgical treatment of malignancy, radiation therapy, or
biological treatment for cancer including immunotherapy while on study, other than
surgical bypass or stent insertion for relief of bile flow blockage

- Patient has a known allergy to soybeans (used in production of Kanglaite Injection)
or Job's Tear (source of active ingredient of Kanglaite Injection), or to gemcitabine

- Patient has NYHA congestive heart failure Class II or higher from any cause

- Patient has unstable angina or history of an MI within 12 months

- Patient is pregnant or lactating
We found this trial at
42
sites
Norwalk, Connecticut 06856
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
5347 Main St # 203
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
?
mi
from
Ames, IA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
?
mi
from
Brick, NJ
Click here to add this to my saved trials
Bronx, New York 10469
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
?
mi
from
Canton, OH
Click here to add this to my saved trials
Casa Grande, Arizona 85222
?
mi
from
Casa Grande, AZ
Click here to add this to my saved trials
?
mi
from
Downey, CA
Click here to add this to my saved trials
Dunmore, Pennsylvania 18512
?
mi
from
Dunmore, PA
Click here to add this to my saved trials
E. Setauket, New York 11733
?
mi
from
E. Setauket, NY
Click here to add this to my saved trials
1717 13th St
Everett, Washington 98201
(425) 297-5500
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
?
mi
from
Everett, WA
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Ft. Lauderdale, Florida 33308
?
mi
from
Ft. Lauderdale, FL
Click here to add this to my saved trials
Galesburg, Illinois 61401
?
mi
from
Galesburg, IL
Click here to add this to my saved trials
Goldsboro, North Carolina 27534
?
mi
from
Goldsboro, NC
Click here to add this to my saved trials
Henderson, Nevada 89052
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Houston, Texas 77203
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77203
?
mi
from
Houston, TX
Click here to add this to my saved trials
Howell, New Jersey 07731
?
mi
from
Howell, NJ
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
?
mi
from
Lemoyne, PA
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Manasquam, New Jersey 08736
?
mi
from
Manasquam, NJ
Click here to add this to my saved trials
100 N Humphreys Blvd
Memphis, Tennessee 38120
(901) 683-0055
The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Muscle Shoals, Alabama 35661
?
mi
from
Muscle Shoals, AL
Click here to add this to my saved trials
New York, New York
?
mi
from
New York, NY
Click here to add this to my saved trials
Purchase, New York 10577
?
mi
from
Purchase, NY
Click here to add this to my saved trials
Redlands, California 92374
?
mi
from
Redlands, CA
Click here to add this to my saved trials
?
mi
from
Skokie, IL
Click here to add this to my saved trials
Soquel, California 95073
?
mi
from
Soquel, CA
Click here to add this to my saved trials
Staten Island, New York 10310
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Sylvania, Ohio 43560
?
mi
from
Sylvania, OH
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Tyler, Texas 75701
?
mi
from
Tyler, TX
Click here to add this to my saved trials