Huachansu & Gemcitabine in Pancreatic Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00837239

Purpose

This protocol is part of a larger grant funded by the NCI to create an international research center to study traditional Chinese medicine (TCM). All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.

Primary End Point:

1. Determine the efficacy of huachansu as measured by progression free survival at 4 months.

Secondary End Points:

Examine the feasibility and safety of treatment using huachansu in combination with gemcitabine in patients with pancreatic cancer.
Determine clinical efficacy by other measures including tumor response, 6-month survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
Monitor patient blood levels of the three main cardiac glycosides that are in huachansu (bufalin, cinobufagin, and resibufogenin). This information will provide evidence to delineate the role of these cardiac glycosides in antitumor activity.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: Gemcitabine Drug: HuaChanSu Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Placebo-controlled, Blinded Phase II Study of Huachansu & Gemcitabine in Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Overall Response (OR) [Progression Free Survival at 4 Months] [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Feasibility, Safety, Toxicity, and QOL (Quality of Life) of patients [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2007
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gemcitabine + HuaChanSu	Drug: Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle). Other Names: Gemcitabine Hydrocholoride Gemzar Drug: HuaChanSu 20 mL/m2 for total 500 mL given as a 2 hour infusion, 5 days a week for 3 weeks then one week off (28 Day Cycle). Other Name: HCS
Experimental: Gemcitabine + Placebo	Drug: Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle). Other Names: Gemcitabine Hydrocholoride Gemzar Drug: Placebo 500 ml saline only administered as a 2 hour infusion by central line.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically/cytologically confirmed unresectable (locally advanced or stage IV) pancreatic adenocarcinoma.
Karnofsky Performance Status > 60 (see Appendix H for definition)
Measurable disease by RECIST criteria must be present. Bone scan abnormalities alone will not be accepted as measurable disease. Lytic lesions seen on plain radiographs will not be accepted as measurable disease but will be evaluated in conjunction with bone scan abnormalities. Pure blastic bone metastases will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease. Irradiated lesions are not considered measurable.
Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
Patients must have adequate organ functions reflected by the laboratory criteria below: Granulocytes >1,500/uL; Hemoglobin >/= 8.0 gm/dL; Platelets > 100,000/uL; Serum creatinine < 2.0 mg/dL; Bilirubin < 1.5 mg/dL; SGPT < 3 x normal; Alk Phos < 3 x normal; Calcium </=11.0 mg/dL
Age >/=18
Patients must not have received any prior chemotherapy. Prior exposure to Traditional Chinese Medicine is allowed provided that at least one week washout time is given prior to initiation of experimental treatment.
Concomitant bisphosphonates are allowed for patients with bone metastases.
Patients with jaundice must have a biliary drainage decompression operation before recruitment.
Ability to understand and the willingness to sign a written informed consent.
Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.

Exclusion Criteria:

Known central nervous system involvement and leptomeningeal disease
Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
Known allergies to the huachansu or toad skin products.
Concurrent infection requiring intravenous antibiotics.
Pregnant or lactating women.
Prior treatment with systemic chemotherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837239

Locations

China
Cancer Hospital Fudan University
Shanghai, China

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Chris Garrett, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00837239 History of Changes
Other Study ID Numbers:	2006-0948
Study First Received:	February 3, 2009
Last Updated:	October 31, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

HuaChanSu
HCS
Gastrointestinal
Gastrointestinal Disease
Metastases
Cancer

Pancreatic cancer
Placebo
Gemcitabine
Gemcitabine Hydrocholoride
Gemzar
Fudan UniversityCancer Hospital

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 February 09, 2012