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Huachansu & Gemcitabine in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00837239
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : July 12, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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:

  1. Examine the feasibility and safety of treatment using huachansu in combination with gemcitabine in patients with pancreatic cancer.
  2. Determine clinical efficacy by other measures including tumor response, 6-month survival, and changes in quality of life (QOL) in patients with pancreatic cancer.
  3. 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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: HuaChanSu Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Blinded Phase II Study of Huachansu & Gemcitabine in Pancreatic Cancer
Study Start Date : June 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gemcitabine + HuaChanSu
Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off + 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).
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
Gemcitabine 1,000 mg/m2 once a week for 3 weeks then 1 week off (28 Day Cycle) + Placebo 500 ml saline only administered as a 2 hour infusion by central line.
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.




Primary Outcome Measures :
  1. Progression Free Survival at 4 Months [ Time Frame: 4 Months ]
    Number of participants without disease progression four months following treatment.


Secondary Outcome Measures :
  1. Median Overall Survival [ Time Frame: Up to 4 Years ]
    Median participants overall survival defined as date of study entry until death, or censored to last known date of survival, reported in days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically/cytologically confirmed unresectable (locally advanced or stage IV) pancreatic adenocarcinoma.
  2. Karnofsky Performance Status > 60 (see Appendix H for definition)
  3. 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.
  4. Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
  5. 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
  6. Age >/=18
  7. 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.
  8. Concomitant bisphosphonates are allowed for patients with bone metastases.
  9. Patients with jaundice must have a biliary drainage decompression operation before recruitment.
  10. Ability to understand and the willingness to sign a written informed consent.
  11. Prior local therapy, e.g., TACE or radiation, is allowed provided that at least 4 weeks washout time is given.

Exclusion Criteria:

  1. Known central nervous system involvement and leptomeningeal disease
  2. 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.
  3. Known allergies to the huachansu or toad skin products.
  4. Concurrent infection requiring intravenous antibiotics.
  5. Pregnant or lactating women.
  6. Prior treatment with systemic chemotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00837239     History of Changes
Other Study ID Numbers: 2006-0948
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012

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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs