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Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer
This study is currently recruiting participants.
Verified by KangLaiTe USA, June 2009
First Received: August 11, 2008   Last Updated: June 8, 2009   History of Changes
Sponsored by: KangLaiTe USA
Information provided by: KangLaiTe USA
ClinicalTrials.gov Identifier: NCT00733850
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Kanglaite Injection plus gemcitabine
Drug: Gemcitabine
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Dose Escalation, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by KangLaiTe USA:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: From randomization until death from any cause ] [ Designated as safety issue: No ]
  • Clinical Benefit Response [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Kanglaite Injection plus Gemcitabine
Drug: Kanglaite Injection plus gemcitabine
Intravenous repeating dose
2: Active Comparator
Gemcitabine
Drug: Gemcitabine
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 "statin" drugs (HMG-CoA reductase inhibitors) for treatment of high cholesterol, including Lipitor, Mevacor, Crestor, and Zocor, or other anti-hyperlipidemic agents, including Atromid-S, Tricor, Lopid, and Niacin
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733850

Locations
United States, Alabama
Northwest Alabama Cancer Center Recruiting
Muscle Shoals, Alabama, United States, 35661
Contact: Sharon Scogin     256-381-1001     scogin_nwacc@comcast.net    
Contact: Lisa Hall     256-764-4200     lhallrn@comcast.net    
Principal Investigator: Hermant Patel            
United States, Arizona
Donald W. Hill, MD Recruiting
Casa Grande, Arizona, United States, 85222
Contact: Chris Appel     520-876-5770 ext 108     mackcruz70@yahoo.com    
Principal Investigator: Donald Hill            
United States, California
St. Helena Hospital Recruiting
St. Helena, California, United States, 94574
Contact: Shellie Klimen     707-967-2698     klimensl@ah.org    
Principal Investigator: Gregory B Smith            
Loma Linda Oncology Medical Group, Inc. Recruiting
Redlands, California, United States, 92374
Contact: Pedro Bernal     909-796-4333     m.pedro.bernal@llomgi.com    
Contact: Eli Rodriguez     909-796-4333     eli.rodriguez@llomgi.com    
Principal Investigator: Imtiaz A Malik            
Cancer Prevention and Treatment Center Recruiting
Soquel, California, United States, 95073
Contact: Cecilia Rivas     831-462-8750     cecy@cybercancer.com    
Principal Investigator: Jennifer J Choate            
Cancer Care Associates of Fresno Medical Group (California Cancer Care) Recruiting
Fresno, California, United States, 93720
Contact: Christyn Anderson     559-326-1222     andersonc@ccaonc.com    
Contact: Joyce Lawrence     559-326-1222     lawrencej@ccaonc.com    
Principal Investigator: Charles Kuzma            
United States, Illinois
Hematology / Oncology of the North Shore Recruiting
Skokie, Illinois, United States, 60076
Contact: Marsha Weller     847-675-3900     mregwell@yahoo.com    
Principal Investigator: Edward Kaplan            
United States, Kentucky
Kentuckiana Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact: Julie Kauzlarich     502-561-8200     jkauzlarich@kci.us    
Contact: Roxanne Smalley     502-561-8200     rsmalley@kci.us    
Principal Investigator: Monte Martin            
United States, Louisiana
Mary Bird Perkins Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70509
Contact: Stephen Herbert     225-215-1204     stephenh@marybird.com    
Principal Investigator: Bryan J Bienvenu            
United States, Nevada
Las Vegas Cancer Center Recruiting
Henderson, Nevada, United States, 89052
Contact: Elizabeth Bergman     702-471-7779     eliznlv@msn.com    
Contact: Valerie Chang     702-471-7779     lijiunv@yahoo.com    
Principal Investigator: Nutan Parikh            
United States, Pennsylvania
Central Pennsylvania Hematology and Medical Oncology Assoc Recruiting
Lemoyne, Pennsylvania, United States, 17043
Contact: Diane Funston     717-737-5767     research3@cphmoa.com    
Contact: Lori Martin     717-737-5767        
Principal Investigator: John D Conroy            
United States, Tennessee
The West Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Tracy Stewart     901-683-0055     tstewart@westclinic.com    
Contact: April Riggins     901-683-0055     ariggins@westclinic.com    
Principal Investigator: Lee S Schwartzberg            
Sponsors and Collaborators
KangLaiTe USA
Investigators
Principal Investigator: Lee S Schwartzberg, MD The West Clinic
  More Information

No publications provided

Responsible Party: KangLaiTe USA ( Michael Hensley, MD )
Study ID Numbers: KLT-PANC-001
Study First Received: August 11, 2008
Last Updated: June 8, 2009
ClinicalTrials.gov Identifier: NCT00733850     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Antiviral Agents
Immunosuppressive Agents
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on August 25, 2009