Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer
NCT ID: NCT00733850
Last Updated: 2015-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
85 participants
INTERVENTIONAL
2008-08-31
2014-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Kanglaite Injection plus Gemcitabine
Kanglaite Injection plus gemcitabine
Intravenous repeating dose
2
Gemcitabine
Gemcitabine
Intravenous repeating dose
Interventions
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Kanglaite Injection plus gemcitabine
Intravenous repeating dose
Gemcitabine
Intravenous repeating dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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KangLaiTe USA
INDUSTRY
Responsible Party
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Principal Investigators
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Lee S Schwartzberg, MD
Role: PRINCIPAL_INVESTIGATOR
The West Clinic
Locations
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Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
Donald W. Hill, MD
Casa Grande, Arizona, United States
East Valley Hematology & Oncology Medical Group
Burbank, California, United States
The Oncology Institute of Hope and Innovation
Downey, California, United States
Cancer Care Associates of Fresno Medical Group (California Cancer Care)
Fresno, California, United States
Loma Linda Oncology Medical Group, Inc.
Redlands, California, United States
Cancer Prevention and Treatment Center
Soquel, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Broward Oncology Associates
Fort Lauderdale, Florida, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Medical and Surgical Specialists
Galesburg, Illinois, United States
Hematology / Oncology of the North Shore
Skokie, Illinois, United States
Hematology Oncology of Indiana
Indianapolis, Indiana, United States
McFarland Clinic
Ames, Iowa, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Research Medical Center
Kansas City, Missouri, United States
Southeast Nebraska Hematology & Oncology Consultants
Lincoln, Nebraska, United States
Las Vegas Cancer Center
Henderson, Nevada, United States
New Jersey Hematology Oncology Associates
Brick, New Jersey, United States
Regional Cancer Care Associates
Howell Township, New Jersey, United States
Atlantic Hematology Oncology Associates
Manasquam, New Jersey, United States
North Shore Hematology Oncology Associates
East Setauket, New York, United States
Arena Oncology Associates
Lake Success, New York, United States
Morton Coleman, MD
New York, New York, United States
Abraham Mittelman, MD
Purchase, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
Bruckner Oncology
The Bronx, New York, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Promedica Cancer Institute
Sylvania, Ohio, United States
Hematology and Oncology Associates of NE PA
Dunmore, Pennsylvania, United States
Central Pennsylvania Hematology and Medical Oncology Assoc
Lemoyne, Pennsylvania, United States
The West Clinic
Memphis, Tennessee, United States
Oncology Consultants PA
Houston, Texas, United States
Oncology Consultants
Houston, Texas, United States
St. Luke's Cancer Center
Houston, Texas, United States
Blood And Cancer Center of East Texas
Tyler, Texas, United States
Tyler Hematology Oncology
Tyler, Texas, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Countries
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References
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Schwartzberg LS, Arena FP, Bienvenu BJ, Kaplan EH, Camacho LH, Campos LT, Waymack JP, Tagliaferri MA, Chen MM, Li D. A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection (KLTi) plus Gemcitabine versus Gemcitabine in Patients with Advanced Pancreatic Cancer. J Cancer. 2017 Jul 3;8(10):1872-1883. doi: 10.7150/jca.15407. eCollection 2017.
Other Identifiers
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KLT-PANC-001
Identifier Type: -
Identifier Source: org_study_id
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