Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer

NCT00733850 | Completed Phase 2 DMC

• 1 other identifier: KLT-PANC-001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 42

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Length of study

Secondary Outcomes (2)

• Objective Response Rate

  Length of study

• Survival

  From randomization until death from any cause

Study Arms (2)

1

EXPERIMENTAL

Kanglaite Injection plus Gemcitabine

Drug: Kanglaite Injection plus gemcitabine

2

ACTIVE COMPARATOR

Gemcitabine

Drug: Gemcitabine

Interventions

Kanglaite Injection plus gemcitabine DRUG

Intravenous repeating dose

Also known as: KLT

1

Gemcitabine DRUG

Intravenous repeating dose

Also known as: Gemzar

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KangLaiTe USA: lead

Study Sites (42)

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, 35661, United States

Location

Donald W. Hill, MD

Casa Grande, Arizona, 85222, United States

Location

East Valley Hematology & Oncology Medical Group

Burbank, California, 91505, United States

Location

The Oncology Institute of Hope and Innovation

Downey, California, 90241, United States

Location

Cancer Care Associates of Fresno Medical Group (California Cancer Care)

Fresno, California, 93720, United States

Location

Loma Linda Oncology Medical Group, Inc.

Redlands, California, 92374, United States

Location

Cancer Prevention and Treatment Center

Soquel, California, 95073, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Broward Oncology Associates

Fort Lauderdale, Florida, 33308, United States

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Pasco Pinellas Cancer Center

New Port Richey, Florida, 34652, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Medical and Surgical Specialists

Galesburg, Illinois, 61401, United States

Location

Hematology / Oncology of the North Shore

Skokie, Illinois, 60076, United States

Location

Hematology Oncology of Indiana

Indianapolis, Indiana, 46260, United States

Location

McFarland Clinic

Ames, Iowa, 50010, United States

Location

Kentuckiana Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70509, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Southeast Nebraska Hematology & Oncology Consultants

Lincoln, Nebraska, 68510, United States

Location

Las Vegas Cancer Center

Henderson, Nevada, 89052, United States

Location

New Jersey Hematology Oncology Associates

Brick, New Jersey, 08724, United States

Location

Regional Cancer Care Associates

Howell Township, New Jersey, 07731, United States

Location

Atlantic Hematology Oncology Associates

Manasquam, New Jersey, 08736, United States

Location

North Shore Hematology Oncology Associates

East Setauket, New York, 11733, United States

Location

Arena Oncology Associates

Lake Success, New York, 11042, United States

Location

Morton Coleman, MD

New York, New York, 10021, United States

Location

Abraham Mittelman, MD

Purchase, New York, 10577, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Bruckner Oncology

The Bronx, New York, 10469, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Promedica Cancer Institute

Sylvania, Ohio, 43560, United States

Location

Hematology and Oncology Associates of NE PA

Dunmore, Pennsylvania, 18512, United States

Location

Central Pennsylvania Hematology and Medical Oncology Assoc

Lemoyne, Pennsylvania, 17043, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Oncology Consultants PA

Houston, Texas, 77024, United States

Location

Oncology Consultants

Houston, Texas, 77024, United States

Location

St. Luke's Cancer Center

Houston, Texas, 77030, United States

Location

Blood And Cancer Center of East Texas

Tyler, Texas, 75701, United States

Location

Tyler Hematology Oncology

Tyler, Texas, 75701, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Related Publications (1)

• 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.

  PMID: 28819385 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

kang-lai-te; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lee S Schwartzberg, MD

  The West Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

US (42)