Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer

A Randomized, Open-Label, 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.

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Kanglaite Injection plus gemcitabine; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Kanglaite Injection plus Gemcitabine	Drug: Kanglaite Injection plus gemcitabine; Intravenous repeating dose; Other Names: KLT
Active Comparator: 2; Gemcitabine	Drug: Gemcitabine; Intravenous repeating dose; Other Names: Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	Length of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	Length of study
Survival	From randomization until death from any cause

Collaborators and Investigators

• Sponsor: KangLaiTe USA
• Investigators: Principal Investigator: Lee S Schwartzberg, MD, The West Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 11, 2008
• First Submitted That Met QC Criteria: August 11, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: KLT-PANC-001