Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00733850
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : June 19, 2015
Information provided by (Responsible Party):
KangLaiTe USA

Brief Summary:

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.

This phase II clinical study was completed in the US in June 2014. The clinical study report was submitted to the FDA in January 2015. The designs of the phase III clinical study for KLT has been cleared by the FDA in May 2015 and will be launched soon.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Kanglaite Injection plus gemcitabine Drug: Gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer
Study Start Date : August 2008
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Kanglaite Injection plus Gemcitabine
Drug: Kanglaite Injection plus gemcitabine
Intravenous repeating dose
Other Name: KLT
Active Comparator: 2
Drug: Gemcitabine
Intravenous repeating dose
Other Name: Gemzar

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Length of study ]
  2. Survival [ Time Frame: From randomization until death from any cause ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 1.1 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 if randomized to the G + K arm of study, or if the patient does not have one, must agree to have one placed if randomized to the G+K arm.

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
  • Patient has used or plans to use another investigational agent within four weeks prior to screening through the entire study period including study termination and the follow-up visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00733850

  Hide Study Locations
United States, Alabama
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Donald W. Hill, MD
Casa Grande, Arizona, United States, 85222
United States, California
East Valley Hematology & Oncology Medical Group
Burbank, California, United States, 91505
The Oncology Institute of Hope and Innovation
Downey, California, United States, 90241
Cancer Care Associates of Fresno Medical Group (California Cancer Care)
Fresno, California, United States, 93720
Loma Linda Oncology Medical Group, Inc.
Redlands, California, United States, 92374
Cancer Prevention and Treatment Center
Soquel, California, United States, 95073
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Florida
Broward Oncology Associates
Ft. Lauderdale, Florida, United States, 33308
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States, 34652
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Medical and Surgical Specialists
Galesburg, Illinois, United States, 61401
Hematology / Oncology of the North Shore
Skokie, Illinois, United States, 60076
United States, Indiana
Hematology Oncology of Indiana
Indianapolis, Indiana, United States, 46260
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70509
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, Nebraska
Southeast Nebraska Hematology & Oncology Consultants
Lincoln, Nebraska, United States, 68510
United States, Nevada
Las Vegas Cancer Center
Henderson, Nevada, United States, 89052
United States, New Jersey
New Jersey Hematology Oncology Associates
Brick, New Jersey, United States, 08724
Regional Cancer Care Associates
Howell, New Jersey, United States, 07731
Atlantic Hematology Oncology Associates
Manasquam, New Jersey, United States, 08736
United States, New York
Bruckner Oncology
Bronx, New York, United States, 10469
North Shore Hematology Oncology Associates
E. Setauket, New York, United States, 11733
Arena Oncology Associates
Lake Success, New York, United States, 11042
Morton Coleman, MD
New York, New York, United States, 10021
Abraham Mittelman, MD
Purchase, New York, United States, 10577
Richmond University Medical Center
Staten Island, New York, United States, 10310
United States, North Carolina
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Promedica Cancer Institute
Sylvania, Ohio, United States, 43560
United States, Pennsylvania
Hematology and Oncology Associates of NE PA
Dunmore, Pennsylvania, United States, 18512
Central Pennsylvania Hematology and Medical Oncology Assoc
Lemoyne, Pennsylvania, United States, 17043
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Oncology Consultants PA
Houston, Texas, United States, 77024
Oncology Consultants
Houston, Texas, United States, 77024
St. Luke's Cancer Center
Houston, Texas, United States, 77030
Blood And Cancer Center of East Texas
Tyler, Texas, United States, 75701
Tyler Hematology Oncology
Tyler, Texas, United States, 75701
United States, Washington
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Sponsors and Collaborators
KangLaiTe USA
Principal Investigator: Lee S Schwartzberg, MD The West Clinic

Responsible Party: KangLaiTe USA Identifier: NCT00733850     History of Changes
Other Study ID Numbers: KLT-PANC-001
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs