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

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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
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Ames, Iowa 50010
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5347 Main St # 203
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1 Tampa General Cir
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4875 Higbee Ave NW
Canton, Ohio 44718
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Casa Grande, Arizona 85222
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1717 13th St
Everett, Washington 98201
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Indianapolis, Indiana 46260
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Lake Success, New York 11042
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Manasquam, New Jersey 08736
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100 N Humphreys Blvd
Memphis, Tennessee 38120
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Muscle Shoals, Alabama 35661
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