Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
KangLaiTe USA
ClinicalTrials.gov Identifier:
NCT00733850
First received: August 11, 2008
Last updated: July 3, 2014
Last verified: July 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 67
Study Start Date: August 2008
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Kanglaite Injection plus Gemcitabine
Drug: Kanglaite Injection plus gemcitabine
Intravenous repeating dose
Other Name: KLT
Active Comparator: 2
Gemcitabine
Drug: Gemcitabine
Intravenous repeating dose
Other Name: Gemzar

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733850

  Show 42 Study Locations
Sponsors and Collaborators
KangLaiTe USA
Investigators
Principal Investigator: Lee S Schwartzberg, MD The West Clinic
  More Information

No publications provided

Responsible Party: KangLaiTe USA
ClinicalTrials.gov Identifier: NCT00733850     History of Changes
Other Study ID Numbers: KLT-PANC-001
Study First Received: August 11, 2008
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014