Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733850
• Other study ID #: KLT-PANC-001
• Status: Completed
• Phase: Phase 2
• First received: August 11, 2008
• Last updated: June 17, 2015
• Start date: August 2008
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: KangLaiTe USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Kanglaite Injection plus gemcitabine
Intravenous repeating dose
• Gemcitabine
Intravenous repeating dose

Locations

Country	Name	City	State
United States	McFarland Clinic	Ames	Iowa
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	New Jersey Hematology Oncology Associates	Brick	New Jersey
United States	Bruckner Oncology	Bronx	New York
United States	East Valley Hematology & Oncology Medical Group	Burbank	California
United States	Gabrail Cancer Center	Canton	Ohio
United States	Donald W. Hill, MD	Casa Grande	Arizona
United States	The Oncology Institute of Hope and Innovation	Downey	California
United States	Hematology and Oncology Associates of NE PA	Dunmore	Pennsylvania
United States	North Shore Hematology Oncology Associates	E. Setauket	New York
United States	Providence Regional Cancer Partnership	Everett	Washington
United States	Cancer Care Associates of Fresno Medical Group (California Cancer Care)	Fresno	California
United States	Broward Oncology Associates	Ft. Lauderdale	Florida
United States	Medical and Surgical Specialists	Galesburg	Illinois
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Las Vegas Cancer Center	Henderson	Nevada
United States	Oncology Consultants	Houston	Texas
United States	Oncology Consultants PA	Houston	Texas
United States	St. Luke's Cancer Center	Houston	Texas
United States	Regional Cancer Care Associates	Howell	New Jersey
United States	Hematology Oncology of Indiana	Indianapolis	Indiana
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Research Medical Center	Kansas City	Missouri
United States	Arena Oncology Associates	Lake Success	New York
United States	Central Pennsylvania Hematology and Medical Oncology Assoc	Lemoyne	Pennsylvania
United States	Southeast Nebraska Hematology & Oncology Consultants	Lincoln	Nebraska
United States	Kentuckiana Cancer Institute	Louisville	Kentucky
United States	Atlantic Hematology Oncology Associates	Manasquam	New Jersey
United States	The West Clinic	Memphis	Tennessee
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	Pasco Pinellas Cancer Center	New Port Richey	Florida
United States	Morton Coleman, MD	New York	New York
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Abraham Mittelman, MD	Purchase	New York
United States	Loma Linda Oncology Medical Group, Inc.	Redlands	California
United States	Hematology / Oncology of the North Shore	Skokie	Illinois
United States	Cancer Prevention and Treatment Center	Soquel	California
United States	Richmond University Medical Center	Staten Island	New York
United States	Promedica Cancer Institute	Sylvania	Ohio
United States	Tampa General Hospital	Tampa	Florida
United States	Blood And Cancer Center of East Texas	Tyler	Texas
United States	Tyler Hematology Oncology	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
KangLaiTe USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		Length of study	No
Secondary	Objective Response Rate		Length of study	No
Secondary	Survival		From randomization until death from any cause	No