Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
KangLaiTe USA |
---|---|
Information provided by: | KangLaiTe USA |
ClinicalTrials.gov Identifier: | NCT00733850 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Kanglaite Injection plus Gemcitabine
|
Drug: Kanglaite Injection plus gemcitabine
Intravenous repeating dose
|
2: Active Comparator
Gemcitabine
|
Drug: Gemcitabine
Intravenous repeating dose
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Northwest Alabama Cancer Center | Recruiting |
Muscle Shoals, Alabama, United States, 35661 | |
Contact: Sharon Scogin 256-381-1001 scogin_nwacc@comcast.net | |
Contact: Lisa Hall 256-764-4200 lhallrn@comcast.net | |
Principal Investigator: Hermant Patel | |
United States, Arizona | |
Donald W. Hill, MD | Recruiting |
Casa Grande, Arizona, United States, 85222 | |
Contact: Chris Appel 520-876-5770 ext 108 mackcruz70@yahoo.com | |
Principal Investigator: Donald Hill | |
United States, California | |
St. Helena Hospital | Recruiting |
St. Helena, California, United States, 94574 | |
Contact: Shellie Klimen 707-967-2698 klimensl@ah.org | |
Principal Investigator: Gregory B Smith | |
Loma Linda Oncology Medical Group, Inc. | Recruiting |
Redlands, California, United States, 92374 | |
Contact: Pedro Bernal 909-796-4333 m.pedro.bernal@llomgi.com | |
Contact: Eli Rodriguez 909-796-4333 eli.rodriguez@llomgi.com | |
Principal Investigator: Imtiaz A Malik | |
Cancer Prevention and Treatment Center | Recruiting |
Soquel, California, United States, 95073 | |
Contact: Cecilia Rivas 831-462-8750 cecy@cybercancer.com | |
Principal Investigator: Jennifer J Choate | |
Cancer Care Associates of Fresno Medical Group (California Cancer Care) | Recruiting |
Fresno, California, United States, 93720 | |
Contact: Christyn Anderson 559-326-1222 andersonc@ccaonc.com | |
Contact: Joyce Lawrence 559-326-1222 lawrencej@ccaonc.com | |
Principal Investigator: Charles Kuzma | |
United States, Illinois | |
Hematology / Oncology of the North Shore | Recruiting |
Skokie, Illinois, United States, 60076 | |
Contact: Marsha Weller 847-675-3900 mregwell@yahoo.com | |
Principal Investigator: Edward Kaplan | |
United States, Kentucky | |
Kentuckiana Cancer Institute | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Julie Kauzlarich 502-561-8200 jkauzlarich@kci.us | |
Contact: Roxanne Smalley 502-561-8200 rsmalley@kci.us | |
Principal Investigator: Monte Martin | |
United States, Louisiana | |
Mary Bird Perkins Cancer Center | Recruiting |
Baton Rouge, Louisiana, United States, 70509 | |
Contact: Stephen Herbert 225-215-1204 stephenh@marybird.com | |
Principal Investigator: Bryan J Bienvenu | |
United States, Nevada | |
Las Vegas Cancer Center | Recruiting |
Henderson, Nevada, United States, 89052 | |
Contact: Elizabeth Bergman 702-471-7779 eliznlv@msn.com | |
Contact: Valerie Chang 702-471-7779 lijiunv@yahoo.com | |
Principal Investigator: Nutan Parikh | |
United States, Pennsylvania | |
Central Pennsylvania Hematology and Medical Oncology Assoc | Recruiting |
Lemoyne, Pennsylvania, United States, 17043 | |
Contact: Diane Funston 717-737-5767 research3@cphmoa.com | |
Contact: Lori Martin 717-737-5767 | |
Principal Investigator: John D Conroy | |
United States, Tennessee | |
The West Clinic | Recruiting |
Memphis, Tennessee, United States, 38120 | |
Contact: Tracy Stewart 901-683-0055 tstewart@westclinic.com | |
Contact: April Riggins 901-683-0055 ariggins@westclinic.com | |
Principal Investigator: Lee S Schwartzberg |
Principal Investigator: | Lee S Schwartzberg, MD | The West Clinic |
Responsible Party: | KangLaiTe USA ( Michael Hensley, MD ) |
Study ID Numbers: | KLT-PANC-001 |
Study First Received: | August 11, 2008 |
Last Updated: | June 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00733850 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Antiviral Agents Immunosuppressive Agents |
Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |