Clinical trial NCT00733850: Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: KangLaiTe USA
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: Length of study
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Length of study
measure: Survival
timeFrame: From randomization until death from any cause
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Casa Grande
country: United States
facility: Donald W. Hill, MD
state: Arizona
city: Burbank
country: United States
facility: East Valley Hematology & Oncology Medical Group
state: California
city: Downey
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Fresno
country: United States
facility: Cancer Care Associates of Fresno Medical Group (California Cancer Care)
state: California
city: Redlands
country: United States
facility: Loma Linda Oncology Medical Group, Inc.
state: California
city: Soquel
country: United States
facility: Cancer Prevention and Treatment Center
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Ft. Lauderdale
country: United States
facility: Broward Oncology Associates
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: New Port Richey
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Galesburg
country: United States
facility: Medical and Surgical Specialists
state: Illinois
city: Skokie
country: United States
facility: Hematology / Oncology of the North Shore
state: Illinois
city: Indianapolis
country: United States
facility: Hematology Oncology of Indiana
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants
state: Nebraska
city: Henderson
country: United States
facility: Las Vegas Cancer Center
state: Nevada
city: Brick
country: United States
facility: New Jersey Hematology Oncology Associates
state: New Jersey
city: Howell
country: United States
facility: Regional Cancer Care Associates
state: New Jersey
city: Manasquam
country: United States
facility: Atlantic Hematology Oncology Associates
state: New Jersey
city: Bronx
country: United States
facility: Bruckner Oncology
state: New York
city: E. Setauket
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: Lake Success
country: United States
facility: Arena Oncology Associates
state: New York
city: New York
country: United States
facility: Morton Coleman, MD
state: New York
city: Purchase
country: United States
facility: Abraham Mittelman, MD
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Sylvania
country: United States
facility: Promedica Cancer Institute
state: Ohio
city: Dunmore
country: United States
facility: Hematology and Oncology Associates of NE PA
state: Pennsylvania
city: Lemoyne
country: United States
facility: Central Pennsylvania Hematology and Medical Oncology Assoc
state: Pennsylvania
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Houston
country: United States
facility: Oncology Consultants PA
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: St. Luke's Cancer Center
state: Texas
city: Tyler
country: United States
facility: Blood And Cancer Center of East Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology Oncology
state: Texas
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
Study officials:
affiliation: The West Clinic
name: Lee S Schwartzberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.