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A Randomized Dose Escalation, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

A Randomized Dose Escalation, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer


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 "statin" drugs (HMG-CoA reductase inhibitors) for
treatment of high cholesterol, including Lipitor, Mevacor, Crestor, and Zocor, or
other anti-hyperlipidemic agents, including Atromid-S, Tricor, Lopid, and Niacin

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Length of study

Safety Issue:

No

Principal Investigator

Lee S Schwartzberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The West Clinic

Authority:

United States: Food and Drug Administration

Study ID:

KLT-PANC-001

NCT ID:

NCT00733850

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Oncology ConsultantsHouston, Texas  77024
Research Medical CenterKansas City, Missouri  64132
Arena Oncology AssociatesGreat Neck, New York  11021
Kentuckiana Cancer InstituteLouisville, Kentucky  40202
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
Tampa General HospitalTampa, Florida  33606
Pasco Pinellas Cancer CenterNew Port Richey, Florida  34652
The West ClinicMemphis, Tennessee  38120
Las Vegas Cancer CenterLas Vegas, Nevada  89102
Norwalk HospitalNorwalk, Connecticut  06856
Medical and Surgical SpecialistsGalesburg, Illinois  61401
McFarland ClinicAmes, Iowa  50010
Blood and Cancer Center of East TexasTyler, Texas  75701
Baptist Cancer InstituteJacksonville, Florida  32207
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
Richmond University Medical CenterStaten Island, New York  10310-1699
Hematology Oncology of IndianaIndianapolis, Indiana  46260
Tyler Hematology OncologyTyler, Texas  75701
Loma Linda Oncology Medical Group, Inc.Redlands, California  92374
Southeast Nebraska Hematology & Oncology ConsultantsLincoln, Nebraska  68516
Donald W. Hill, MDCasa Grande, Arizona  85222
Cancer Care Associates of Fresno Medical Group (California Cancer Care)Fresno, California  93720
Cancer Prevention and Treatment CenterSoquel, California  95073
Hematology / Oncology of the North ShoreSkokie, Illinois  60076
Promedica Cancer InstituteSylvania, Ohio  43560
Hematology and Oncology Associates of NE PADunmore, Pennsylvania  18512
Central Pennsylvania Hematology and Medical Oncology AssocLemoyne, Pennsylvania  17043